ONC Privacy and Security Best Practices for HIPAA

Guide to
Privacy and Security
of Electronic Health
Information
Version 2.0
April 2015
The information contained in this Guide is not intended to serve as legal advice nor should it substitute for legal counsel.
The Guide is not exhaustive, and readers are encouraged to seek additional detailed technical guidance to supplement
the information contained herein.

Guide to
Privacy and Security of Electronic Health Information 2
Table of Contents
List of Acronyms ..................................................................................................................................4
Foreword.............................................................................................................................................5
Revised Guide to Privacy and Security of Electronic Health Information.................................................5
Introduction and Purpose..................................................................................................................... 5
Context.................................................................................................................................................. 6
Actions and Programs ....................................................................................................................... 6
Federal Organizations ....................................................................................................................... 6
Chapter 1.............................................................................................................................................8
Why Do Privacy and Security Matter?...................................................................................................... 8
Increasing Patient Trust and Information Integrity Through Privacy and Security ..............................8
Chapter 2........................................................................................................................................... 10
Your Practice and the HIPAA Rules.........................................................................................................10
Understanding Provider Responsibilities Under HIPAA......................................................................10
What Types of Information Does HIPAA Protect? ..............................................................................11
Who Must Comply with the HIPAA Rules? .........................................................................................11
The HIPAA Privacy Rule....................................................................................................................... 13
HIPAA Privacy Rule Limits Uses and Disclosures of Patient Information........................................14
Chapter 3........................................................................................................................................... 22
Understanding Patients’ Health Information Rights...............................................................................22
Patients’ Rights and Your Responsibilities..........................................................................................22
Notice of Privacy Practices (NPP)....................................................................................................22
Patient Access to Information.........................................................................................................23
Amending Patient Information .......................................................................................................23
Accounting of Disclosures...............................................................................................................24
Rights to Restrict Information.........................................................................................................24
Right to Confidential Communications...........................................................................................24
Designated Record Set........................................................................................................................ 25
Chapter 4........................................................................................................................................... 26
Understanding Electronic Health Records, the HIPAA Security Rule, and Cybersecurity.......................26
The HIPAA Security Rule ..................................................................................................................... 26
How to Keep Your Patients’ Health Information Secure with an EHR................................................28
Working with Your EHR and Health IT Developers.............................................................................29
Cybersecurity ...................................................................................................................................... 30
Chapter 5........................................................................................................................................... 32
Medicare and Medicaid EHR Incentive Programs Meaningful Use Core Objectives that Address Privacy
and Security ............................................................................................................................................ 32
Meaningful Use................................................................................................................................... 32
General Overview of Stage 1 and Stage 2 Meaningful Use ................................................................33

Guide to
Chapter 6........................................................................................................................................... 35
Sample Seven-Step Approach for Implementing a Security Management Process...............................35
Introduction ........................................................................................................................................ 35
How to Get Started on Security ..........................................................................................................35
Sample Seven-Step Approach for Implementing a Security Management Process...........................37
Step 1: Lead Your Culture, Select Your Team, and Learn ...............................................................37
Step 2: Document Your Process, Findings, and Actions..................................................................40
Step 3: Review Existing Security of ePHI (Perform Security Risk Analysis).....................................41
Step 4: Develop an Action Plan.......................................................................................................43
Step 5: Manage and Mitigate Risks.................................................................................................46
Step 6: Attest for Meaningful Use Security-Related Objective.......................................................53
Step 7: Monitor, Audit, and Update Security on an Ongoing Basis................................................54
Chapter 7........................................................................................................................................... 56
Breach Notification, HIPAA Enforcement, and Other Laws and Requirements .....................................56
Civil Penalties ...................................................................................................................................... 56
Criminal Penalties ............................................................................................................................... 56
The Breach Notification Rule: What to Do If You Have a Breach .......................................................57
Risk Assessment Process for Breaches ...........................................................................................58
Reporting Breaches............................................................................................................................. 59
Investigation and Enforcement of Potential HIPAA Rules Violations .................................................60
Penalties for Violations ................................................................................................................... 60
Other Laws and Requirements ...........................................................................................................61
Tables
Table 1: Overview of HHS Entities ................................................................................................................ 7
Table 2: Examples of Potential Information Security Risks with Different Types of EHR Hosts.................43
Table 3: Five Security Components for Risk Management.........................................................................45
Table 4: Comparison of Secured and Unsecured PHI .................................................................................58
Table 5: Overview of Penalties ................................................................................................................... 60
Table 6: Overview of Other Laws and Requirements .................................................................................61

Guide to
List of Acronyms
AHIMA American Health Information Management Association
AIDS Acquired Immune Deficiency Syndrome
BA Business Associate
BAA Business Associate Agreement
CD Compact Disc
CE Covered Entity
CEHRT Certified Electronic Health Record Technology
CFR Code of Federal Regulations
CHPS Certified in Healthcare Privacy and Security
CMS Centers for Medicare and Medicaid Services
CPHIMS Certified Professional in Healthcare Information and Management Systems
CPOE Computerized Provider Order Entry
DVD Digital Video Disc
EHR Electronic Health Record
EP Eligible Professional
ePHI Electronic Protected Health Information
FAQ Frequently Asked Questions
FERPA Family Educational Rights and Privacy Act
FR Federal Register
GINA Genetic Information Nondiscrimination Act
Health IT Health Information Technology
HHS U.S. Department of Health and Human Services
HIE Health Information Exchange
HIMSS Healthcare Information and Management Systems Society
HIO Health Information Organization
HIPAA Health Insurance Portability and Accountability Act
HITECH Health Information Technology for Economic and Clinical Health
HIV Human Immunodeficiency Virus
IT Information Technology
NIST National Institute of Standards and Technology
NPP Notice of Privacy Practices
NPRM Notice of Proposed Rulemaking
OCR Office for Civil Rights
ONC Office of the National Coordinator for Health Information Technology
PHI Protected Health Information
PHR Personal Health Record
REC Regional Extension Center
SRA Security Risk Assessment
USC United States Code

Guide to
Foreword
Revised Guide to Privacy and Security of Electronic
Health Information
Introduction and Purpose
Everyone has a role to play in
the privacy and security of
electronic health information
— it is truly a shared
responsibility. The Office of the
National Coordinator for Health
Information Technology (ONC)
provides resources to help you
succeed in your privacy and
security responsibilities. This
Guide to Privacy and Security of
Electronic Health Information
(referred to as “Guide”) is an
example of just such a tool.
The intent of the Guide is to
help health care providers ―
especially Health Insurance Portability and Accountability Act (HIPAA) Covered Entities (CEs) and
Medicare Eligible Professionals (EPs)1
from smaller organizations ― better understand how to integrate
federal health information privacy and security requirements into their practices. This new version of
the Guide provides updated information about compliance with the Medicare and Medicaid Electronic
Health Record (EHR) Incentive Programs’ privacy and security requirements as well as the HIPAA Privacy,
Security, and Breach Notification Rules.
The U.S. Department of Health and Human Services (HHS), via ONC, the Centers for Medicare and
Medicaid Services (CMS), and the Office for Civil Rights (OCR), supports privacy and security through a
variety of activities. These activities include the meaningful use of certified EHRs, the Medicare and
Medicaid EHR Incentive Programs, enforcement of the HIPAA Rules, and the release of educational
resources and tools to help providers and hospitals mitigate privacy and security risks in their practices.
1
The following are considered “Eligible Professionals”: doctors of medicine or osteopathy, doctors of dental surgery or dental
medicine, doctors of podiatry, doctors of optometry, and chiropractors. (Source: http://www.cms.gov/Regulations-and-
Guidance/Legislation/EHRIncentivePrograms/downloads/beginners_guide.pdf)

Guide to
This Guide is not intended to serve as legal advice or as recommendations based on a provider or
professional’s specific circumstances. We encourage providers and professionals to seek expert advice
when evaluating the use of this Guide.
Context
This Guide is designed to help you work to comply with federal requirements and federal programs’
requirements administered through HHS agencies and offices. These key programs and organizations
involved in health information privacy and security are described below.
Actions and Programs
• The HIPAA Privacy, Security, and Breach Notification Rules, as updated by the HIPAA Omnibus
Final Rule2
in 2013, set forth how certain entities, including most health care providers, must
protect and secure patient information. They also address the responsibilities of Business
Associates (BAs), which include EHR developers working with health care providers.
• In 2011, CMS initiated the Medicare and Medicaid EHR Incentive Programs.3,4
The programs are
referred to as “EHR Incentive Programs” or “Meaningful Use” Programs throughout this Guide.
Meaningful Use encourages health care organizations to adopt EHRs through a staged approach.
Each stage contains core requirements that providers must meet; privacy and security are
included in the requirements.
Federal Organizations
This Guide frequently refers to federal organizations within HHS that have a distinct health information
technology (health IT) role. These organizations are summarized in Table 1.
2
In January 2013, HHS issued a Final Rule that modified the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules
as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act and the Genetic Information
Nondiscrimination Act (GINA). This Final Rule is often referred to as the HIPAA Omnibus Final Rule. These modifications are
incorporated throughout this Guide. The Rule can be accessed at http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf.
3
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html?redirect=/ehrincentiveprograms/
4
In 2012, CMS finalized the Stage 2 Meaningful Use criteria that an EP must follow to continue to participate in the Medicare and
Medicaid EHR Incentive Programs. Several Stage 2 criteria address privacy and security. The 2012 regulations also revised Stage 1
criteria that address privacy and security. The regulations can be accessed at http://www.gpo.gov/fdsys/pkg/FR-2012-09-
04/pdf/2012-21050.pdf.

Guide to
Table 1: Overview of HHS Entities
Federal Office/Agency Health IT-Related Responsibilities Website
Centers for Medicare and
Medicaid Services (CMS)
• Oversees the Meaningful Use Programs www.cms.gov
Office for Civil Rights (OCR) • Administers and enforces the HIPAA Privacy,
Security, and Breach Notification Rules
• Conducts HIPAA complaint investigations,
compliance reviews, and audits
www.hhs.gov/ocr
Office of the National
Coordinator for Health
Information Technology (ONC)
• Provides support for the adoption and promotion
of EHRs and health information exchange
• Offers educational resources and tools to assist
providers with keeping electronic health
information private and secure
www.HealthIT.gov
A fourth federal entity mentioned in this Guide is the National Institute of Standards and
Technology (NIST), an agency of the U.S. Department of Commerce. NIST sets computer security
standards for the federal government and publishes reports on topics related to information technology
(IT) security. While the reports are intended for the federal government, they are available for public
use and can provide valuable information to support a strong security program for your practice setting.
To review NIST publications that are relevant to the HIPAA Security Rule, visit
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityruleguidance.html5
and
scroll to the bottom of the page.
Other state and federal laws may require additional privacy and security actions that are not addressed
in this Guide.
5
Note that the NIST special publications on this website are provided as an informational resource and are not legally binding
guidance for CEs to comply with the requirements of the HIPAA Security Rule.

Guide to
Chapter 1
Why Do Privacy and Security Matter?
Increasing Patient Trust and Information
Integrity Through Privacy and Security
To reap the promise of digital health information to achieve
better health outcomes, smarter spending, and healthier
people, providers and individuals alike must trust that an
individual’s health information is private and secure. If your
patients lack trust in Electronic Health Records (EHRs) and
Health Information Exchanges (HIEs), feeling that the
confidentiality and accuracy of their electronic health
information is at risk, they may not want to disclose health
information to you.6
Withholding their health information could
have life-threatening consequences.
This is one reason why it’s so important for you to ensure the
privacy and security of health information. When patients trust
you and health information technology (health IT) enough to
share their health information, you will have a more complete
picture of patients’ overall health and together, you and your
patient can make more-informed decisions.
In addition, when breaches of health information occur, they can have serious consequences for your
organization, including reputational and financial harm or harm to your patients. Poor privacy and
security practices heighten the vulnerability of patient information in your health information system,
increasing the risk of successful cyber-attack.
To help cultivate patients’ trust, you should:
• Maintain accurate information in patients’ records
• Make sure patients have a way to request electronic access to their medical record and know
how to do so
6
http://www.healthit.gov/sites/default/files/022414_hit_attitudesaboutprivacydatabrief.pdf. See also Agaku, I.T., Adisa, A.O., Ayo-
Yusuf, O.A., & Connolly, G.N. (2014, March-April). Concern about security and privacy, and perceived control over collection and
use of health information are related to withholding of health information from healthcare providers. Journal of the American Medical
Informatics Association, 21(2), 374-8. Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23975624.

Guide to
• Carefully handle patients’ health information to protect their privacy
• Ensure patients’ health information is accessible to authorized representatives when needed
Protecting patients’ privacy and securing their health information stored in an EHR is a core requirement
of the Medicare and Medicaid EHR Incentive Programs.7
(The EHR Incentive Programs are also referred
to as the “Meaningful Use” Programs throughout this Guide.) Your practice — not your EHR developer
— is responsible for taking the steps needed to protect the confidentiality, integrity, and availability
of health information in your EHR.
Effective privacy and security measures help you meet Meaningful Use requirements while also helping
your clinical practice meet requirements of the HIPAA Rules and avoid costly civil money penalties for
violations,8
as discussed in Chapter 7.
7
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/index.html
8
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/

Guide to
Chapter 2
Your Practice and the HIPAA Rules
Understanding Provider Responsibilities Under HIPAA
The Health Insurance Portability and Accountability Act
(HIPAA) Rules provide federal protections for patient
health information held by Covered Entities (CEs) and
Business Associates (BAs) and give patients an array of
rights with respect to that information. This suite of
regulations includes the Privacy Rule, which protects
the privacy of individually identifiable health
information; the Security Rule, which sets national
standards for the security of electronic Protected Health
Information (ePHI); and the Breach Notification Rule,
which requires CEs and BAs to provide notification
following a breach of unsecured Protected Health Information (PHI). CEs must comply with the HIPAA
Privacy,10
Security,11
and Breach Notification12
Rules. BAs must comply with the HIPAA Security Rule
and Breach Notification Rule as well as certain provisions of the HIPAA Privacy Rule.
Whether patient health information is on a
computer, in an Electronic Health Record
(EHR), on paper, or in other media, providers
have responsibilities for safeguarding
the information by meeting the requirements
of the Rules.
This chapter provides a broad overview of the
HIPAA privacy and security requirements.
You may also need to be aware of any
additional applicable federal, state, and local
laws governing the privacy and security of
health information.13
9
http://www.healthit.gov/providers-professionals/regional-extension-centers-recs
10
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
11
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/
12
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/index.html
13
State laws that are more privacy-protective than HIPAA continue to apply.
Where Can I Get Help or
More Information?
Regional Extension Centers (RECs)9
across the nation can offer
customized, on-the-ground
assistance to providers who are
implementing HIPAA privacy and
security protections.

Guide to
What Types of Information Does HIPAA Protect?
The Privacy Rule protects most individually identifiable health information held or transmitted by a CE or
its BA, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information
“protected health information” or “PHI.” Individually identifiable health information is information,
including demographic information, that relates to:
• The individual’s past, present, or future physical or mental health or condition,
• The provision of health care to the individual, or
• The past, present, or future payment for the provision of health care to
the individual.
In addition, individually identifiable health information identifies the individual or there is
a reasonable basis to believe it can be used to identify the individual.
For example, a medical record, laboratory report, or hospital bill would be PHI if information contained
therein includes a patient’s name and/or other identifying information.
The HIPAA Rules do not apply to individually identifiable health information in your practice’s
employment records or in records covered by the Family Educational Rights and Privacy Act (FERPA),
as amended.14
Who Must Comply with the HIPAA Rules?
CEs15
and BAs must comply with the HIPAA Rules. CEs include:
• Health care providers who conduct certain standard administrative and financial transactions in
electronic form, including doctors, clinics, hospitals, nursing homes, and pharmacies. Any health
care provider who bills electronically (such as a current Medicare provider) is a CE.
• Health plans
• Health care clearinghouses
A BA is a person or entity, other than a workforce member16
(e.g., a member of your office staff), who
performs certain functions or activities on your behalf, or provides certain services to or for you, when
the services involve the access to, or the use or disclosure of, PHI.17
BA functions or activities include
14
20 United States Code (USC) 1232g; 45 Code of Federal Regulations (CFR) 160.103;
http://www2.ed.gov/policy/gen/guid/fpco/doc/ferpa-hipaa-guidance.pdf
15
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html
16
Workforce members are employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a
covered entity, is under the direct control of such covered entity, whether or not they are paid by the covered entity. 45 CFR
160.103.
17
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html and 45 CFR 160.103.

Guide to
claims processing, data analysis, quality assurance, certain patient safety activities, utilization review,
and billing.
BA services to a CE can be legal, actuarial, accounting, consulting, data aggregation, information
technology (IT) management, administrative, accreditation, or financial services.18
Many contractors
that perform services for a CE are not BAs because the services do not involve the use or disclosure
of PHI.
Examples of BAs include:
• Health Information Organizations or Exchanges (HIOs/HIEs)
• E-prescribing gateways
• Other person who provides data transmission services (that involve routine access to PHI)
to a CE
• A subcontractor to a BA that creates, receives, maintains, or transmits PHI on behalf of the BA
• An entity that a CE contracts with to provide patients with access to a Personal Health Record
(PHR) on behalf of a CE
Following are some scenarios to help illustrate who is and who is not a BA. This is not an exhaustive list
of examples.
• You hire a company to turn your accounting records from visits into coded claims for submission
to an insurance company for payment; the company is your BA for payment purposes.19
• You hire a case management service to identify your diabetic and pre-diabetic patients at high
risk of non-compliance and recommend optimal interventions to you for those patients.
The case management service is a BA acting on your behalf by providing case management
services to you.
• You hire a web designer to maintain your practice’s website and improve its online access for
patients seeking to view/download or transmit their health information. The designer must
have regular access to patient records to ensure the site is working correctly. The web designer
is a BA.
• Not a BA: You hire a web designer to maintain your practice’s website. The designer installs the
new electronic version of the Notice of Privacy Practices (NPP) and improves the look and feel of
the general site. However, the designer has no access to PHI. The web designer is not a BA.
• Not a BA: You hire a janitorial company to clean your office nightly, including vacuuming your
file room. If the janitors do not have access to PHI, then the janitors are not BAs.
18
Ibid.
19
Ibid.

Guide to
When a CE discloses PHI to health plans for payment, there is no BA relationship because the health plan
is not performing a function or activity for the CE. While the CE may have an agreement to accept
discounted fees as reimbursement for services provided to health plan members, that agreement does
not create a BA relationship because neither entity is acting on behalf of or providing a service to
the other.20
A CE can be the BA of another CE when it
performs the functions or activities for the CE.
For example, if a hospital provides billing
services for attending physicians, the hospital is
a BA of the physicians for the purposes of
preparing those bills. Other functions the
hospital performs regarding the attending
physicians, such as quality review of patient
outcomes for hospital privileging purposes, do
not create a BA relationship because the
activities are not done on behalf of the
physician. Finally, a health care provider is not a
BA of another health care provider when it uses
and discloses PHI for treatment purposes. So the
attending physician and the hospital do not have
a BA relationship as they share PHI to treat their
mutual patients.
When a CE uses a contractor or other non-workforce member to perform BA services or activities, the
Rules require that the CE include certain protections for the information in a BA agreement. In the
agreement, a CE must impose specified written safeguards on the PHI accessed, used, or disclosed by
the BA. Moreover, a CE may not contractually authorize its BA to make any use or disclosure of PHI that
would violate the Rule.
BAs are directly liable for violating the HIPAA Security Rule and Breach Notification Rule as well as
certain provisions of the Privacy Rule. Liability may attach to BAs, even in situations in which the BA has
not entered into the required agreement with the CE.
Specific requirements for CEs and BAs are discussed below; also see Step 5D of Chapter 6.
The HIPAA Privacy Rule
The Privacy Rule establishes national standards for the protection of certain health information.
The Privacy Rule standards address the use and disclosure of PHI as well as standards for individuals’
privacy rights to understand and control how their health information is used and shared, including
rights to examine and obtain a copy of their health records as well as to request corrections.
20
Ibid.

Guide to
The imposition of civil and criminal penalties is possible for violations of HIPAA and the HIPAA Privacy
Rule. Learn more about HIPAA enforcement on the Office for Civil Rights (OCR) website21
and in
Chapter 7. The Privacy Rule is discussed further on the Privacy Rule page of the OCR website.22
HIPAA Privacy Rule Limits Uses and Disclosures of Patient Information
This section provides examples of how the Privacy Rule may apply to your practice.
Do I Need to Inform My Patients about How I Use or Disclose Their Health Information?
Generally, yes, a CE must prominently post and distribute an NPP. The notice must describe the ways in
which the CE may use and disclose PHI. The notice must state the CE’s duties to protect privacy, provide
an NPP, and abide by the terms of the current notice. The notice must describe individuals’ rights,
including the right to complain to the U.S. Department of Health and Human Services (HHS) and to the
CE if they believe their privacy rights have been violated. The notice must include a point of contact for
further information and for making complaints to the CE. CEs must act in accordance with their notices.
The Rule also contains specific distribution requirements for health care providers and health plans.
In addition to providing this
notice to patients at the initial
visit, your practice must make
its NPP available to any patient
upon request (discussed in
Chapter 3). Chapter 6, Step 5C,
provides an overview about
new notification requirements
resulting from the 2013
Privacy Rule modifications.
You may want to start with
and personalize for your
practice the model NPPs for
providers24
that were
developed by OCR in
collaboration with the Office
of the National Coordinator for
Health Information Technology
(ONC). Your REC or medical association also may be able to suggest some NPP templates that comply
with the updated requirements. Note that your state health information privacy law may require you to
add other information to your notice.
21
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/
22
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/
23
http://www.hhs.gov/ocr/privacy/hipaa/modelnotices.html
24
http://www.healthit.gov/providers-professionals/model-notices-privacy-practices
Notice of Privacy Practices (NPP)
HHS provides model NPPs23
that you can download and
personalize for your practice’s use. These model notices reflect
the changes required by the HIPAA Omnibus Final Rule. You will
notice that NPPs must include the following information:
• How the CE may use and disclose an individual’s PHI
• The individual’s rights with respect to the information
including a statement that the CE is required by law to
about the CE’s privacy policies
and how the individual may exercise these rights,
•
including how the individual may complain to the CE
The CE’s legal duties with respect to the information,
maintain the privacy of PHI
• Whom individuals can contact for further information

Guide to
Do I Have to Get My Patients’ Permission to Use or Disclose Their Health Information
with Another Health Care Provider, Health Plan, or Business Associate?
In general, you as a CE may use and disclose PHI for your own treatment, payment, and health care
operations activities ― and other permissible or required purposes consistent with the HIPAA Privacy
Rule ― without obtaining a patient’s written permission (e.g., consent or authorization).
A CE also may disclose PHI for:
• The treatment activities of another health care provider,
• The payment activities of another CE and of any health care provider, or
• The health care operations of another CE when:
o Both CEs have or have had a relationship with the individual
o The PHI pertains to the relationship
o The data requested is the minimum necessary
o The health care operations are:
 Quality assessment or improvement activities
 Review or assessment of the quality or competence of health professionals, or
 Fraud and abuse detection or compliance.
An exception applies to most uses and disclosures of psychotherapy notes that may be kept by a
provider from the EHR; a CE cannot disclose psychotherapy notes without an individual’s written
authorization.
Except for disclosures to other health care providers for treatment purposes, you must make reasonable
efforts to use or disclose only the minimum amount of PHI needed to accomplish the intended purpose
of the use or disclosure. This is called the minimum necessary standard.25
When this minimum necessary
standard applies to a use or disclosure, a CE may not use or disclose the entire medical record for a
particular purpose, unless it can specifically justify the whole record as the amount reasonably needed
for the purpose.
When Are Patient Authorizations Not Required for Disclosure?
• Information Sharing Needed for Treatment – You may disclose, without a patient’s
authorization, PHI about the patient as necessary for treatment, payment, and health care
operations purposes. Treatment is the provision, coordination, or management of health care
and related services for an individual by one or more health care providers, including
consultation between providers regarding a patient and referral of a patient by one provider to
25
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/minimumnecessary.html

Guide to
another. A disclosure of PHI by one CE for the treatment activities undertaken by another CE is
fundamental to the nature of health care.
• Disclosures to Family, Friends, and Others Involved in the Care of the Individual as well as for
Notification Purposes – To make disclosures to family and friends involved in the individual’s
care or for notification purposes, or to other persons whom the individual identifies, you must
obtain informal permission by asking the individual outright, or by determining that the
individual did not object in circumstances that clearly gave the individual the opportunity to
agree, acquiesce, or object. For example, if a patient begins discussing health information while
family or friends are present in the examining room, this is a “circumstance that clearly gave the
individual the opportunity to agree, acquiesce, or object.” You do not need a written
authorization to continue the discussion.
Where the individual is
incapacitated, in an emergency
situation, or not available, a CE
generally may make such
disclosures, if the provider
determines through his/her
professional judgment that such
action is in the best interests of
the individual.
You must limit the PHI disclosed
to what is directly relevant to that
person’s involvement in the
individual’s care or payment for
care. Similarly, a CE may rely on
an individual’s informal permission to use or disclose PHI for the purpose of notifying (including
identifying or locating) family members, personal representatives, or others responsible for the
individual’s care, of the individual’s location, general condition, or death.26
OCR’s website
contains additional information about disclosures to family members and friends in fact sheets
developed for consumers27
and providers.28
• Information Needed to Ensure Public Health and Safety – You may disclose PHI without
individual authorization in the following situations:
o To send immunization records to schools. Immunization records about a student or
prospective student of a school can be disclosed to the school without written
authorization — as long as your practice has a parent or guardian’s oral agreement if the
student is a minor, or from the individual if the individual is an adult or emancipated
26
45 CFR 164.510(b). Also, search the HHS Frequently Asked Questions (FAQs) at
http://www.hhs.gov/ocr/privacy/hipaa/faq/index.html.
27
http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/sharing-family-friends.pdf
28
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/provider_ffg.pdf

Guide to
minor. Your practice must document such oral agreement. Such disclosures can only be
made in instances where state law requires the school to have such information before
admitting the student. In addition, the PHI disclosed in such an instance must be limited
to proof of immunization.29
o To a public health authority that is authorized by law to collect or receive such
information for the purpose of preventing or controlling disease, injury, or disability.
This would include, for example, the reporting of disease or injury; reporting vital
events, such as births or deaths; and conducting public health surveillance,
investigations, or interventions.30
o To a foreign government agency (at the direction of a public health authority) that is
acting in collaboration with the public health authority.31
o To persons at risk of contracting or spreading a disease or condition if other law, such as
state law, authorizes the CE to notify such individuals as necessary to prevent or control
the spread of the disease.32
• Information Needed to Prevent or Lessen Imminent Danger – You may disclose PHI that you
believe is necessary to prevent or lessen a serious and imminent threat to a person or the
public, when such disclosure is made to someone you believe can prevent or lessen the threat
(including the target of the threat). CEs may also disclose to law enforcement if the information
is needed to identify or apprehend an escapee or violent criminal.33
• Disclosures in Facility Directories – In health care facilities where a directory of patient contact
information is maintained, a CE may rely on an individual’s informal permission to list in its
facility directory the individual’s name, general condition, religious affiliation, and location in the
provider’s facility. The CE may then disclose the individual’s condition and location in the facility
to anyone asking for the individual by name and also may disclose religious affiliation to clergy.
Members of the clergy are not required to ask for the individual by name when inquiring about
patient religious affiliation.
Informal permission may be obtained by asking the individual outright, or by circumstances that
clearly give the individual the opportunity to agree, acquiesce, or object. Where the individual is
incapacitated, in an emergency situation, or not available, CEs generally may make such uses
and disclosures if, in the exercise of their professional judgment, the use or disclosure is
determined to be in the best interests of the individual.
• Note: Health information of an individual that has been deceased for more than 50 years is not
PHI and therefore not subject to the Privacy Rule use and disclosure standards. You may use and
disclose the information without patient authorization.
29
45 CFR 164.512(b)(1)(vi).
30
45 CFR 164.501 and 164.512(b)(1)(i).
31
45 CFR 164.512(b)(1)(i).
32
45 CFR 164.512(b)(1)(iv).
33
45 CFR 164.512(j).

Guide to
For more information on disclosures for public health purposes and circumstances that permit the
disclosure of PHI without a patient authorization, visit the Health Information Privacy Public Health web
page.34
When Are Patient Authorizations Required for Disclosure?
A CE must obtain the individual’s written authorization for any use or disclosure of PHI that is not for
treatment, payment, or health care operations or otherwise permitted or required by the Privacy Rule.
A CE may not condition treatment,
payment, enrollment, or benefits eligibility
on an individual granting an authorization,
except in limited circumstances.
An authorization must be written in
specific terms. It may allow use and
disclosure of PHI by the CE seeking the
authorization or by a third party. Examples
of disclosures that would require an
individual’s authorization include
disclosures to a life insurer for coverage
purposes, disclosures to an employer of
the results of a pre-employment physical
or lab test, or disclosures to a
pharmaceutical firm for their own
marketing purposes.
All authorizations must be in plain language and contain specific information regarding the information
to be disclosed or used, the person(s) disclosing and receiving the information, expiration, right to
revoke in writing, and other data.
Specific purposes that require an individual’s written authorization include:
• Psychotherapy Notes – Your practice and your BA must obtain an individual’s authorization to
use or disclose psychotherapy notes35
with the following exceptions:
o The CE who originated the notes may use them for treatment.
o A CE may use or disclose, without an individual’s authorization, the psychotherapy notes
for its own training; to defend itself in legal proceedings brought by the individual; for
HHS to investigate or determine the CE’s compliance with the Privacy Rules; to avert a
34
http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/publichealth/index.html
35
42 CFR 164.501: “Psychotherapy notes means notes recorded (in any medium) by a health care provider who is a mental health
professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint, or family
counseling session and that are separated from the rest of the individual’s medical record. Psychotherapy notes excludes
medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment
furnished, results of clinical test, and any summary of the following items: Diagnosis, functional status, the treatment plan,
symptoms, prognosis, and progress to date.”

Guide to
serious and imminent threat to public health or safety; to a health oversight agency for
lawful oversight of the originator of the psychotherapy notes; for the lawful activities of
a coroner or medical examiner; or as required by law.
• Marketing Activities – Your practice and your BA must obtain a patient’s authorization prior to
using or disclosing PHI for marketing activities. Marketing is any communication about a product
or service that encourages recipients to purchase or use the product or service. If you are being
paid for such use or disclosure in marketing, the authorization must state that payment is
involved. However, the Privacy Rule carves out some health-related activities from this definition
of marketing. Activities not considered to be marketing, and therefore not subject to the
marketing authorization requirements, are:
o Communications for treatment of the individual; and
o Communications for case management or care coordination for the individual, or to
direct or recommend alternative treatments, therapies, health care providers, or
care settings to the individual if there is no compensation involved for making
the communication. For example:
 You contract with a health coach to provide case management and to coordinate
the care you provide for your patients with other physicians.
 An endocrinologist shares a patient’s medical record with several behavior
management programs to determine which program best suits the ongoing
needs of the individual patient.
 A hospital social worker shares medical record information with various nursing
homes in the course of recommending that the patient be transferred from a
hospital bed to a nursing home.
• PHI Sales and Licensing – Your practice and your BA may not sell PHI without patient
authorization (including the licensing of PHI). A sale is a disclosure of PHI in which your practice
or your BA directly or indirectly receives payment from the recipient of the PHI.
o The following are examples of actions that do not constitute “sale of PHI” and therefore
do not require patient authorization:
 Public health reporting activities
 Research, if the remuneration is reasonable and cost-based
 Treatment and payment
 Sale or merger of your practice
 Due diligence
 A payment you make to a BA for services the BA supplied

Guide to
• Research – Special rules apply with regard to clinical research, bio-specimen banking, and all
other forms of research not involving psychotherapy notes. In some circumstances, patient
authorization is required. You may want to obtain specific guidance on these requirements from
sources like the main OCR Health Information Privacy Research web page36
and the National
Institutes of Health HIPAA Privacy Rule Information for Researchers web page.37
What is De-Identified PHI?
The Privacy Rule does not restrict the use or disclosure of de-identified health information. De-identified
health information neither identifies nor provides a reasonable basis to identify an individual. If data is
de-identified in the manner prescribed by HIPAA, it is not PHI. Increasingly researchers are seeking and
using de-identified clinical data for health system improvement activities.
The Privacy Rule permits a CE or its BA to create and freely
use and disclose information that is not individually
identifiable by following the Privacy Rule’s de-identification
requirements. These provisions allow the entity to use
and disclose information that neither identifies nor
provides a reasonable basis to identify an individual.
The Rule provides two de-identification methods: 1) a
formal determination by a qualified expert; or 2) the
removal of 18 specified individual identifiers as well as
absence of actual knowledge by the CE that the remaining
information could be used alone or in combination with
other information to identify the individual. You may use a
BA to de-identify the PHI.
Note that just removing the identifiers specified in the
Privacy Rule may NOT make information de-identified.38
However, once PHI is de-identified in accordance with the
Privacy Rule, it is no longer PHI, and thus may be used and
disclosed by your practice or your BA for any purpose
(subject to any other applicable laws).
What About Patient Information Pertaining to Behavioral Health or Substance Abuse?
The HIPAA Rules apply equally to all PHI, including individually identifiable behavioral health or
substance abuse information that your practice collects or maintains in a patients’ record. Thus, for
HIPAA Rule compliance purposes, you would protect such behavioral health or substance abuse
information that your practice collects in the same way that you protect other PHI.39
However,
36
http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/
37
http://privacyruleandresearch.nih.gov/pr_02.asp
38
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/deidentificationworkshop2010.html
39
Learn more about the HIPAA Privacy Rule and sharing information related to mental health at
http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/mhguidance.html.

Guide to
remember that the Privacy Rule restricts sharing of psychotherapy notes without patient authorization.
In addition, other federal regulations govern health information related to substance abuse and mental
health services. Also, state privacy laws may be more stringent than the HIPAA Rules regarding
information about individuals’ behavioral health and substance abuse; please review your
specific state’s laws.
The HIPAA Privacy Rule allows you to share a patient’s health information, except for psychotherapy
notes, with another CE for treatment, payment, and health care operations without a patient’s
authorization, as long as no other state law applies. For additional guidance on the HIPAA Privacy Rule
and sharing information related to mental health, please see OCR’s Guidance at
http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/mhguidance.html.
Federal and State Privacy Laws — Which Prevail?
The HIPAA Rules provide a floor of federal protections for PHI. However, the Rules are not the only laws
that address the protection of health information. In some instances, a more protective state law may
forbid a disclosure or require you to get an individual’s written authorization to disclose health
information where HIPAA would otherwise permit you to disclose the information without the
individual’s permission. The HIPAA Rules do not override such state laws that do not conflict with the
Rules and offer greater privacy protections. If a state law is less protective than the HIPAA Rules but a
CE or BA could comply with both, both apply — such as when a state law permits disclosure without an
authorization and the Privacy Rule requires an authorization, the entity could comply by obtaining
authorization.

Guide to
Chapter 3
Understanding Patients’ Health Information Rights
Patients’ Rights and Your Responsibilities
The Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule standards address the use and disclosure of
individuals’ Protected Health Information (PHI) by organizations
subject to the Privacy Rule. The Rule also addresses standards for
individuals’ privacy rights so that patients can understand and
control how their health information is used and disclosed.
The Office for Civil Rights (OCR) explains these rights and other
requirements more fully on its website, including in its Summary
of the HIPAA Privacy Rule,40
its Frequently Asked Questions
(FAQs),41
and its Understanding Health Information Privacy
page.42
As a health care provider, you have responsibilities to patients
under the HIPAA Privacy Rule, including providing them with a
Notice of Privacy Practices (NPP) and responding to their requests
for access, amendments, accounting of disclosures, restrictions on
uses and disclosures of their health information, and confidential
communications.
The Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (also known as
“Meaningful Use” Programs) add new rights for patients who want their health care providers to
transmit their electronic PHI (ePHI) to themselves or other caregivers.
Notice of Privacy Practices (NPP)
If you are a Covered Entity (CE), you must provide your patients with a notice of your privacy practices.
Your notice must contain certain elements, including:
• Description of how your practice may use or disclose (share) an individual’s PHI
• Specification of individuals’ rights, including the right to complain to the U.S. Department of
Health and Human Services (HHS) and to your practice if they believe their privacy rights have
been violated (many of these rights are described below)
40
http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html
41
http://www.hhs.gov/ocr/privacy/hipaa/faq/index.html
42
http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

Guide to
• Details of your practice’s duties to protect privacy, provide an NPP, and abide by
the terms of the notice (OCR provides extensive information for providers,
including customizable model notices, on its website. Visit
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html for
requirements and http://www.hhs.gov/ocr/privacy/hipaa/modelnotices.html for model notices.)
Patient Access to Information
Patients have the right to inspect and receive a copy of their PHI in a designated record set, which
includes information about them in your medical and billing records. (Designated record sets are
explained at the end of this chapter.) Generally, a CE must grant or deny the request for access within 30
days of receipt of the request. If the health information is held in electronic format and the patient
requests to receive it in a specific electronic format, a CE must provide it in the electronic format
requested by the patient if it is readily producible. If the format is not available, the CE must provide the
health information in an electronic format
agreed to by the patient and CE.
Under the Meaningful Use requirements,
additional rights apply as well. For example,
as your practice gains the capability to
demonstrate Stage 2 Meaningful Use, you
will be required to respond to any requests
from your patients to transmit an electronic
copy of PHI directly to persons or entities
they designate. An individual may request
that you transmit PHI in your records to his
or her Personal Health Record (PHR) or to
another physician. Your EHR developers, as
your BAs, must cooperate in this obligation.
Amending Patient Information
Under the HIPAA Rules, patients have the right to request that your practice amend their PHI in a
designated record set. Generally, a CE must honor the request unless it has determined that the
information is accurate and complete. The CE must act on an individual’s request for an amendment no
later than 60 days after the receipt of the request. If you accept an amendment request, your practice
must make the appropriate amendment by identifying the records in the designated record set that are
affected by the amendment and providing a link to the location of the amendment. If you refuse the
request, additional requirements, including the patient’s right to file a statement of disagreement that
stays with the health record, apply.

Guide to
Accounting of Disclosures
Individuals have a right to receive an accounting of disclosures43
of their PHI made by your practice to a
person or organization outside of your practice. An accounting of disclosures is a listing of the:
• Names of the person or entity to whom the PHI was disclosed
• Date on which the PHI was disclosed
• Description of the PHI disclosed
• Purpose of the disclosure
This right to an accounting is limited, as the Rule does not require you to include disclosures made for
treatment, payment, heath care operations, and several other purposes and situations.
Your practice is required to provide an accounting of disclosures for the six years prior to the date on
which the accounting was requested.
Rights to Restrict Information
Individuals have the right to request that your practice restrict certain:
• Uses and disclosures of PHI for treatment, payment, and health care operations
• Disclosures to persons involved in the individual’s health care or payment for health care
• Disclosures to notify family members or others about the individual’s general condition,
location, or death
If your patient (or another person on behalf of the individual) has fully paid out-of-pocket for a service
or item and also requests that the PHI not be disclosed to his/her health plan, your practice cannot
disclose the PHI to a health plan for payment or health care operations.44
You should implement policies
and procedures that ensure this directive can be carried out.
Right to Confidential Communications
Your practice must accommodate reasonable requests by your patients to receive communications from
you by the means or at the locations they specify. For example, they may request that appointment
reminders be left on their work voicemail rather than home phone voicemail.
43
OCR has issued a Notice of Proposed Rulemaking (NPRM) proposing changes to the right to accounting provisions in the Privacy
Rule pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act. Learn more at
http://blog.cms.gov/2015/01/29/cms-intends-to-modify-requirements-for-meaningful-use/.
44
45 Code of Federal Regulations (CFR) 164.522(a)(1)(vi).

Guide to
Designated Record Set
Given that the HIPAA rights of access and amendment are specific to a CE’s designated record set,
review your practice’s policy about your designated record set to confirm that the policy specifies that
EHRs are a component of the set.
A designated record set is a group of records that your practice or your Business Associate (BA)
(if applicable) maintains to make decisions about individuals. For health care providers, the designated
record set includes (but is not limited to) a patient’s medical records and billing records. CEs are
responsible for determining what records should be included as part of the designated record set.
For more information about designated record sets, review OCR’s guidance on the HIPAA Privacy Rule’s
Right of Access and Health Information Technology.45
45
http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/healthit/eaccess.pdf

Guide to
Chapter 4
Understanding Electronic Health Records, the HIPAA
Security Rule, and Cybersecurity
To support patient care, providers store
electronic Protected Health Information
(ePHI) in a variety of electronic systems,
not just Electronic Health Records (EHRs).
Knowing this, providers must remember
that all electronic systems are vulnerable to
cyber-attacks and must consider in
their security efforts all of their systems
and technologies that maintain ePHI.46
(See Chapter 6 for more information
about security risk analysis.)
While a discussion of ePHI security goes far
beyond EHRs, this chapter focuses on EHR
security in particular.
The HIPAA Security Rule
The Health Insurance Portability and
Accountability Act (HIPAA) Security Rule47
establishes a national set of minimum security
standards for protecting all ePHI that a Covered
Entity (CE) and Business Associate (BA) create,
receive, maintain, or transmit. The Security Rule
contains the administrative, physical, and
technical safeguards that CEs and BAs must
put in place to secure ePHI.
46
Refer to the booklet “Partners in Integrity” at http://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-
Integrity-Education/Provider-Education-Toolkits/Downloads/understand-prevent-provider-idtheft.pdf for more information about
medical identity theft and fraud prevention.
47
48
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/index.html
49
http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
50
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/index.html
51
http://healthit.gov/providers-professionals/ehr-privacy-security/resources
Resources
• HIPAA Requirements,48
in detail
• HIPAA Privacy Rule,49
in detail
• HIPAA Security Rule,50
in detail
• Privacy and Security Resources51

Guide to
These Security Rule safeguards can help health care providers avoid some of the common security gaps
that could lead to cyber-attack intrusions and data loss. Safeguards can protect the people, information,
technology, and facilities that health care providers depend on to carry out their primary mission: caring
for their patients.
The Security Rule has several types of safeguards and requirements which you must apply:
1. Administrative Safeguards52
– Administrative safeguards are administrative actions, policies,
and procedures to prevent, detect, contain, and correct security violations. Administrative
safeguards involve the selection, development, implementation, and maintenance of security
measures to protect ePHI and to manage the conduct of workforce members in relation to the
protection of that information. A central requirement is that you perform a security risk analysis
that identifies and analyzes risks to ePHI and then implement security measures to reduce the
identified risks.
2. Physical Safeguards53
– These safeguards are physical measures, policies, and procedures to
protect electronic information systems and related buildings and equipment from natural and
environmental hazards and unauthorized intrusion.54
These safeguards are the technology and
the policies and procedures for its use that protect ePHI and control access to it.
3. Organizational Standards55
– These standards require a CE to have contracts or other
arrangements with BAs that will have access to the CE’s ePHI. The standards provide the specific
criteria required for written contracts or other arrangements.
4. Policies and Procedures56
– These standards require a CE to adopt reasonable and appropriate
policies and procedures to comply with the provisions of the Security Rule. A CE must maintain,
until six years after the date of their creation or last effective date (whichever is later), written
security policies and procedures and written records of required actions, activities, or
assessments. A CE must periodically review and update its documentation in response to
environmental or organizational changes that affect the security of ePHI.
Visit the Office for Civil Rights (OCR) website57
for a full overview of security standards and required
protections for ePHI under the Security Rule.
52 http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/adminsafeguards.pdf
53
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/physsafeguards.pdf
54
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/techsafeguards.pdf
55
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/pprequirements.pdf
56
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/pprequirements.pdf
57

Guide to
How to Keep Your Patients’ Health Information Secure with an EHR
Your practice is responsible for taking the steps
needed to protect the confidentiality, integrity,
and availability of ePHI maintained in your EHR.
Having an EHR affects the types and
combinations of safeguards you will need
to keep your patients’ health information
confidential. EHRs also bring new
responsibilities for safeguarding your patients’
health information in an electronic form.
To uphold patient trust as your practice
continues to adopt and use an EHR or other
electronic technology for collection and use
of ePHI, and to comply with HIPAA Security
Rule and Meaningful Use requirements, your
practice must conduct a security risk analysis
(sometimes called “security risk assessment”).
(See Chapter 6 for more discussion on security
risk analysis.) The risk analysis process will
guide you through a systematic examination
of many aspects of your health care practice
to identify potential security weaknesses
and flaws.
Many health care providers will need to
make changes to reduce risks and to comply
with the HIPAA Rules and Meaningful Use
requirements. Fortunately, properly
configured and certified EHRs58
can
provide more protection to ePHI than
paper files provided. (See Step 5A in
Chapter 6 for more information about using
electronic capabilities to help safeguard
patients’ information.)
58
http://oncchpl.force.com/ehrcert
59
http://csrc.nist.gov/publications/nistpubs/800-111/SP800-111.pdf
Your EHR Software and Hardware
Most EHRs and related equipment have
security features built in or provided as part of
a service, but they are not always configured
or enabled properly.
As the guardian of ePHI, it is up to you — along
with your designated staff members — to learn
about these basic features and ensure they are
functioning and are updated when necessary.
You and your staff must keep up-to-date with
software upgrades and available patches.
Remember, security risk analysis and
mitigation is an ongoing responsibility for your
practice. Vigilance should be part of your
practice’s ongoing activities.
Encryption 101
Encryption is a method of converting an
original message of regular text into encoded
text. The text is encrypted by means of an
algorithm (a type of formula). If information is
encrypted, there is a low probability that
anyone other than the receiving party who has
the key to the code or access to another
confidential process would be able to decrypt
(translate) the text and convert it into plain,
comprehensible text. For more information
about encryption, review the National Institute
of Standards and Technology (NIST) Special
Publication 800-111, Guide to Storage
Encryption Technologies for End User Devices.59

Guide to
Working with Your EHR and Health IT Developers
When working with your EHR and health information technology (health IT) developers, you may want
to ask the following questions to help understand the privacy and security practices they put in place.60
• When my health IT developer installs its software for my practice, does its implementation
process address the security features listed below for my practice environment?
o ePHI encryption
o Auditing functions
o Backup and recovery routines
o Unique user IDs and strong passwords
o Role- or user-based access controls
o Auto time-out
o Emergency access
o Amendments and accounting of disclosures
• Will the health IT developer train my staff on the above features so my team can update and
configure these features as needed?
• How much of my health IT developer’s training covers privacy and security awareness,
requirements, and functions?
• How does my backup and recovery system work?
o Where is the documentation?
o Where are the backups stored?
o How often do I test this recovery system?
• When my staff is trying to communicate with the health IT developer’s staff, how will each party
authenticate its identity? For example, how will my staff know that an individual who contacts
them is the health IT developer representative and not a hacker trying to pose as such?
• How much remote access will the health IT developer have to my system to provide support and
other services? How will this remote access be secured?
• If I want to securely email with my patients, will this system enable me to do that as required by
the Security Rule?
60
For additional information about questions to ask health IT developers, see the Questions for EHR Developers document at
http://bit.ly/EHRdevqs.

Guide to
Cybersecurity
An Internet connection is a necessity to conduct the many online activities that can be part of EHR and
ePHI use. Exchanging patient information electronically, submitting claims electronically, generating
electronic records for patients’ requests, and e-prescribing are all examples of online activities that rely
on cybersecurity practices to safeguard systems and information.
Cybersecurity refers to ways to prevent, detect, and
respond to attacks against or unauthorized access
against a computer system and its information.
Cybersecurity protects your information or any form of
digital asset stored in your computer or in any digital
memory device.
It is important to have strong cybersecurity practices
in place to protect patient information, organizational
assets, your practice operations, and your personnel,
and of course to comply with the HIPAA Security Rule.61
Cybersecurity is needed whether you have your EHR
locally installed in your office or access it over the
Internet from a cloud service provider.
The Office of the National Coordinator for Health
Information Technology (ONC) offers online
Cybersecurity information,62
including the Top 10 Tips
for Cybersecurity in Health Care, to help you reduce
your risk. For a full overview of security standards and
required protections for ePHI under the HIPAA Security
Rule, visit OCR’s HIPAA Security Rule web page.63
61
62
http://www.healthit.gov/providers-professionals/cybersecurity-shared-responsibility
63
64
http://www.healthit.gov/providers-professionals/your-mobile-device-and-health-information-privacy-and-security
The Threat of Cyber-Attacks
Most everyone has seen news reports
of cyber-attacks against, for example,
national retail chains or the
information networks of the federal
government. Health care providers
may believe that if they are small and
low profile, they will escape the
attention of the “hackers” who are
running these attacks. Yet every day
there are new attacks aimed
specifically at small to mid-size
organizations because they are less
likely to be fully protecting
themselves. Criminals have been
highly successful at penetrating these
smaller organizations and carrying
out their activities, while their
unfortunate victims are unaware
until it is too late.
Mobile Devices
The U.S. Department of Health and Human Services (HHS) has put together a collection of
tips and information64
to help you protect and secure health information that you may
access, receive, and store on mobile devices such as smartphones, laptops, and tablets.

Guide to
Email and Texting
Consumers increasingly want to communicate electronically with their providers through
email or texting. The Security Rule requires that when you send ePHI to your patient,
you send it through a secure method and that you have a reasonable belief that it will
be delivered to the intended recipient. The Security Rule, however, does not apply to
the patient. A patient may send health information to you using email or texting that is
not secure. That health information becomes protected by the HIPAA Rules when you
receive it.
In this environment of more online access and great demand by consumers for near real-
time communications, you should be careful to use a communications mechanism that
allows you to implement the appropriate Security Rule safeguards, such as an email
system that encrypts messages or requires patient login, as with a patient portal. If you
use an EHR system that is certified under ONC’s 2014 Certification Rule, your EHR should
have the capability of allowing your patients to communicate with your office through the
office’s secure patient portal.65
If you attest to Meaningful Use and use a certified EHR system, you should be able to
communicate online with your patients. The EHR system should have the appropriate
mechanisms in place to support compliance with the Security Rule. You might want to
avoid other types of online or electronic communication (e.g., texting) unless you first
confirm that the communication method meets, or is exempt from, the Security Rule.66
65
45 CFR 170.315(e)(3).
66
45 CFR 164.312(e)(1).

Guide to
Chapter 5
Medicare and Medicaid EHR Incentive Programs
Meaningful Use Core Objectives that Address Privacy
and Security
Meaningful Use
In the Medicare and Medicaid Electronic
Health Record (EHR) Incentive Programs
(also called “Meaningful Use” Programs), the
Centers for Medicare and Medicaid Services
(CMS) set staged requirements for providers
to demonstrate progressively more
integrated use of EHRs and receive incentive
payments for such use.
The first version (1.2) of this Guide discussed
two of the Stage 1 core objectives that
relate to privacy and security requirements.
This updated Guide focuses on Stage 1 and
Stage 2 core objectives that address privacy
and security, but it does not address menu
objectives, clinical quality measures, or
Stage 3. Visit the CMS Medicare and
Medicaid EHR Incentive Programs web
page68
for information about incentive
payment year requirements.
67
https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/
68
https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/
Privacy in Meaningful Use
Simply stated, Meaningful Use privacy
requirements address patients’ rights both to:
1. Have their health information protected
from unauthorized access; and
2. Access their health information.
Security in Meaningful Use
The Meaningful Use security requirements
protect Protected Health Information (PHI)
against unauthorized access. The program
requires Stage 1 and 2 core objectives that
can be found on the CMS website.67

Guide to
General Overview of Stage 1 and Stage 2 Meaningful Use
Meaningful Use69
must be demonstrated by:
• Using the capabilities of Certified EHR Technology (CEHRT) adopted by the U.S. Department of
Health and Human Services (HHS) as standards, implementation specifications, and certification
criteria (in the Office of the National Coordinator for Health Information Technology’s Standards
and Certification Criteria regulations),70
and
• Meeting CMS-defined criteria through a phased approach based on anticipated technology and
capabilities development.
To define meaningful use, CMS sought to balance the sometimes competing considerations of improving
health care quality, encouraging widespread EHR adoption, promoting innovation, and avoiding
imposing excessive or unnecessary burdens on health care providers.71
The Stage 1 Meaningful Use criteria, consistent with other provisions of Medicare and Medicaid law,
focuses on:
• Electronically capturing health information in a structured format;
• Using that information to track key clinical conditions and communicating that information for
care coordination purposes (whether that information is structured or unstructured, but in
structured format whenever feasible);
• Implementing clinical decision support tools to facilitate disease and medication management;
• Using EHRs to engage patients and families; and
• Reporting clinical quality measures and public health information.72
The Stage 2 Meaningful Use criteria, consistent with other provisions of Medicare and Medicaid law,
expanded upon the Stage 1 criteria to encourage the use of health information technology (health IT) for
continuous quality improvement at the point of care and the exchange of information in the most
structured format possible. Examples of such use include the electronic transmission of orders entered
using Computerized Provider Order Entry (CPOE) and the electronic transmission of diagnostic test
results (such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac imaging, nuclear
medicine tests, pulmonary function tests, genetic tests, genomic tests and other such data needed to
diagnose and treat disease).73
69
http://www.healthit.gov/policy-researchers-implementers/meaningful-use
70
79 Federal Register (FR) 54429. See also the “ONC Fact Sheet: 2015 Edition Health IT Certification Criteria, Base EHR
Definition, and ONC Health IT Certification Program Modifications Proposed Rule” at http://www.healthit.gov/sites/default/files/ONC-
Certification-Program-2015-Edition-Fact-Sheet.pdf.
71
75 FR 44321.
72
75 FR 44321.
73
77 FR 64755.

Guide to
To demonstrate Meaningful Use, providers must meet measures and report the use of their practices’
EHRs to CMS via attestation. The Meaningful Use Programs define Eligible Professionals (EPs) as doctors
of medicine or osteopathy, dental surgery or dental medicine, podiatric medicine, optometry, and
chiropractic medicine.74
Review the CMS flow chart75
for assistance with determining if you are an EP
and to determine whether to select Medicare or Medicaid to demonstrate Meaningful Use.
Both Meaningful Use Stage 176
and Stage 277
require participating providers to “attest” that they have
met certain objectives and measures regarding the use of the EHRs for patient care. The attestation is
effectively your confirmation or statement that your practice has met those requirements.
In the Medicare and Medicaid EHR
Incentive Programs, specific
Meaningful Use requirements
incorporate many HIPAA privacy and
security requirements for electronic
PHI (ePHI). Basic cybersecurity
practices are needed to protect the
confidentiality, integrity, and
availability of health information in
the EHR system. These protections
are essential whether the EHR is
installed on a server in your office or
hosted on your behalf by a
developer over the Internet.
74
EPs may not be hospital-based. Hospital-based EPs are any provider who furnishes 90% or more of their services in a hospital
setting (inpatient or emergency room).
75
http://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/downloads/eligibility_flow_chart.pdf
76
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Meaningful_Use.html
77
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Stage_2.html

Guide to
Chapter 6
Sample Seven-Step Approach for Implementing a
Security Management Process
Introduction
This chapter describes a sample seven-step approach
that could be used to implement a security
management process in your organization and includes
help for addressing security-related requirements of
Meaningful Use for the Medicare and Medicaid
Electronic Health Record (EHR) Incentive Programs.
The Meaningful Use requirements for privacy and
security (discussed in Chapter 5) are grounded in the
Health Insurance Portability and Accountability Act
(HIPAA) Security Rule. This approach does not cover all
the requirements of Meaningful Use and the HIPAA
Rules, but following this approach may help you fulfill your compliance responsibilities. This is a sample
approach for security management, although occasionally we note related privacy activities.
How to Get Started on Security
Before you start, ask your local Regional Extension Center (REC)78
where you can get help. In addition:
• Check the Office of the National Coordinator for Health Information Technology (ONC) Health IT
Privacy and Security Resources web page.79
• Review the Office for Civil Rights (OCR) Security Rule Guidance Material.80
• Look at the OCR audit protocols.81
• Let your EHR developer(s) know that health information security is one of your major goals in
adopting an EHR.
• Check with your membership associations to see if they have training resource lists
or suggestions.
78
http://healthit.gov/rec
79
http://www.healthit.gov/providers-professionals/ehr-privacy-security/resources
80
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityruleguidance.html
81
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/protocol.html
SampleSeven-StepApproachfor
ImplementingaSecurityManagementProcess

Guide to
• Check to see if your local community college82
offers any applicable training.
• Discuss with your practice staff, and any other partners you have, how they can help you fulfill
your HIPAA Rules responsibilities.
To implement a security management process in your organization, an organized approach to privacy
and security is necessary (see Step 2 later in this chapter).
The security management process standard is a requirement in the HIPAA Security Rule. Conducting a
risk analysis is one of the requirements that provides instructions to implement the security
management process standard. ONC worked with OCR to create a Security Risk Assessment (SRA) Tool83
to help guide health care providers (from small practices) through the risk assessment process. Use of
this tool is not required by the HIPAA Security Rule but is meant to provide helpful assistance.
Before discussing the sample seven-step approach to help providers implement a security management
process, one clarification must be emphasized. The scope of a risk analysis for the EHR Incentive
Programs security requirements is much narrower than the scope of a risk analysis for the HIPAA
Security Rule security management process standard.
The risk analysis requirement in the HIPAA Security Rule is much more expansive. It requires you to
assess the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all the
electronic Protected Health Information (ePHI) that an organization creates, receives, maintains, or
transmits — not just the ePHI maintained in Certified EHR Technology (CEHRT). This includes ePHI in
other electronic systems and all forms of electronic media, such as hard drives, floppy disks, compact
discs (CDs), digital video discs (DVDs), smart cards or other storage devices, personal digital assistants,
transmission media, or portable electronic media.84
In addition, you will need to periodically review
your risk analysis to assess whether changes in your environment necessitate updates to your
security measures.
Under the HIPAA Security Rule, the frequency of reviews will vary among providers. Some providers may
perform these reviews annually or as needed depending on circumstances of their environment. Under
the EHR Incentive Programs, the reviews are required for each EHR reporting period. For Eligible
Professionals (EPs), the EHR reporting period will be 90 days or a full calendar year, depending on the
provider’s year of participation in the program.
82
http://www.healthit.gov/policy-researchers-implementers/community-college-consortia
83
http://healthit.gov/providers-professionals/security-risk-assessment-tool
84
It’s not just the ePHI in EHRs but also in practice management systems, claim processing systems, billing, patient flow (bed
management), care and case management, document scanning, clinical portals, and dozens of other ancillary systems that don’t
meet the definition of CEHRT.

Guide to
Sample Seven-Step Approach for Implementing a Security Management
Process
The sample seven steps which will be discussed here are:
Step 1: Lead Your Culture, Select Your Team, and Learn
Step 2: Document Your Process, Findings, and Actions
Step 3: Review Existing Security of ePHI (Perform Security Risk Analysis)
Step 4: Develop an Action Plan
Step 5: Manage and Mitigate Risks
Step 6: Attest for Meaningful Use Security-Related Objective
Step 7: Monitor, Audit, and Update Security on an Ongoing Basis
Step 1: Lead Your Culture, Select Your Team, and Learn
Your leadership — especially your emphasis on the
importance of protecting patient information — is vital
to your practice’s privacy and security activities. Your
commitment to an organized plan and approach to
integrating privacy and security into your practice
is important.
This first step in your seven-step approach presents six
actions that you should take to set the stage for
implementing an effective security management
process for your organization. Each of these six actions
is discussed below.
1A. Designate a Security Officer(s)
1B. Discuss HIPAA Security Requirements with
Your EHR Developer
1C. Consider Using a Qualified Professional to
Assist with Your Security Risk Analysis
1D. Use Tools to Preview Your Security Risk Analysis
1E. Refresh Your Knowledge Base of the HIPAA Rules
1F. Promote a Culture of Protecting Patient Privacy and Securing Patient Information
Step 1A: Designate a Security Officer(s)
Your security officer will be responsible for developing and maintaining your security practices to meet
HIPAA requirements. This person could be part of your EHR adoption team and should be able to work
effectively with others.
A security officer is responsible for protecting your patients’ ePHI from unauthorized access by
working effectively with others to safeguard patient information. At various times, the officer will

Guide to
need to coordinate with your privacy officer (if a different person), practice manager, information
technology (IT) administrator or consultant, your EHR developer, and legal counsel.
When you designate your officer(s), be sure to:
• Record all officer assignments in a permanent documentation file (this file should focus on
HIPAA compliance efforts), even if you are the officer(s).
• Discuss your expectations for the officer and his/her accountability. Note that you, as a Covered
Entity (CE), retain ultimate responsibility for HIPAA compliance.
• Enable your designated officer(s) to develop a full understanding of the HIPAA Rules so they can
succeed in their roles. For example, allow them time to participate in privacy and security
presentations, seminars, and webinars and to read and review the Final Rules and the analysis
and summaries on the ONC Health IT Privacy and Security Resources web page,85
including the
helpful OCR audit protocols.86
Have them use the ONC Cybersecure training games87
as a useful
training tool.
Step 1B: Discuss HIPAA Security Requirements with Your EHR Developer
As you prepare for the security risk analysis, meet with your EHR developer to understand how your
system can be implemented in a manner consistent with the HIPAA requirements and those for
demonstrating Stage 1 and Stage 2 Meaningful Use (see Chapters 4 and 5).
• Before you purchase an EHR, perform your due diligence by discussing and confirming privacy
and security compliance requirements and product capabilities. Refer to the listing of CEHRT
developers88
as you proceed.
• If you have implemented an EHR, confirm your practice’s understanding of the overall functions
that your EHR product offers and then assess your current security settings.
• You would want to make sure that the EHR system can be configured to your policies and
procedures and that the EHR will sign a Business Associate Agreement (BAA) that reflects your
expectations. Confirm any planned additional capabilities that you need or that your EHR
developer is responsible for providing, especially if any are required to demonstrate Meaningful
Use. Ask the developer for its pricing for training staff on those functions, developing relevant
policies and procedures, and correcting security-setting deficiencies in the EHR system.
Step 1C: Consider Using a Qualified Professional to Assist with Your Security
Risk Analysis
Your security risk analysis must be conducted in a manner consistent with the HIPAA Security Rule, or
you will lack the information necessary to effectively protect ePHI. Note that doing the analysis in-house
85
86
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/protocol.html
87
http://www.healthit.gov/providers-professionals/privacy-security-training-games
88
http://oncchpl.force.com/ehrcert?q=chpl

Guide to
may require an upfront investment of your time and a staff member’s time to understand and address
electronic information security issues and the HIPAA Security Rule.
• A qualified professional’s expertise and
focused attention can often yield quicker
and more reliable results than if your
staff does an in-house risk analysis in a
piecemeal process spread over several
months. Certification (see box at right)
can be one indicator of qualifications.
The professional will suggest ways to
mitigate risks so you can avoid the
need to research and evaluate
options yourself.
• Talk to several sources of potential
assistance. If you contract with a
professional, ONC recommends that
you use a professional who has relevant
certification and direct experience
tailoring a risk analysis to medical
practices with a similar size and
complexity as yours.
You are still ultimately responsible for the
security risk analysis even if you hire a
professional for this activity. Further, the security
risk analysis will require your direct oversight and
ongoing involvement.
The security risk analysis process is an
opportunity to learn as much as possible about
health information security. See Step 3 in this
chapter for more discussion about security
risk analyses.
Step 1D: Use Tools to Preview Your
Security Risk Analysis
Have your security officer or security risk
professional consultant use tools available on the
ONC and OCR websites to get a preliminary sense of potential shortcomings in how your practice
protects patient information. A single listing of areas of focus or a checklist does not fulfill the security
risk analysis requirement, but these types of tools will help everyone get ready for needed
Certification in Health
Information Security
Some professionals have a certification
in health information. For example, the
Healthcare Information and Management
Systems Society (HIMSS) and the American
Health Information Management
Association (AHIMA) are two organizations
that offer certifications upon successful
completion of an exam.
Certified in Healthcare Privacy
and Security (CHPS)
This credential is designated to
professionals who are responsible
for safeguarding patient information.
This credential signifies expertise in
planning, executing, and administering
privacy and security protection programs
in health care organizations and
competence in a specialized skill set in
the privacy and security aspects of health
information management.
Certified Professional in
Healthcare Information and
Management Systems (CPHIMS)
CPHIMS is a professional certification
program for health care information and
management systems professionals.

Guide to
improvements. Keep the results as part of your documentation (see Step 2). Consider the SRA Tool89
and
OCR Guidance on Risk Analysis90
for more thorough guidance in evaluating your level of risk.
Step 1E: Refresh Your Knowledge Base of the HIPAA Rules
Learn about the HIPAA Rules, state laws, and other privacy and security requirements that also
require compliance.
Step 1F: Promote a Culture of Protecting Patient Privacy and Securing
Patient Information
Privacy and security are best achieved when the overall atmosphere in your office emphasizes
confidentiality and protecting of patient information. Culture sets the tone that will:
• Consistently communicate your expectations that all members of your workforce protect
patients’ health information
• Guide your workforce’s efforts to comply with, implement, and enforce your privacy and
security policies and procedures
• Remind staff why securing patient information is important to patients and the medical practice
Step 2: Document Your Process,
Findings, and Actions
Documentation of a risk analysis and
HIPAA-related policies, procedures,
reports, and activities is a requirement
under the HIPAA Security Rule. Also, the
Centers for Medicare and Medicaid
Services (CMS) advise all providers who
attest for the EHR Incentive Programs
to retain all relevant records that
support attestation.
Documentation shows how you did the
security risk analysis and implemented
safeguards to address the risks
identified in your risk analysis. (See the
box at right for additional items to
include in your documentation folder.)
Over time, your security documentation
folder will become a tool that helps
your security procedures be more
89
http://healthit.gov/providers-professionals/security-risk-assessment-tool
90
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidance.html
Examples of Records to Retain
Contents should include, but not be limited to,
the following:
• Your policies and procedures
• Completed security checklists
• Training materials presented to staff and
volunteers; any associated certificates
of completion
• Updated BA agreements
• Security risk analysis report
• EHR audit logs that show both utilization of
security features and efforts to monitor
users’ actions
• Risk management action plan or other
documentation (that shows appropriate
safeguards are in place throughout your
organization), implementation timetables,
and implementation notes
• Security incident and breach information

Guide to
efficient. Your workforce will be able to reference this master file of security findings, decisions, and
actions. Further, the information will be more accurate than if your workforce tries to reconstruct past
decisions and actions. These records will be essential if you are ever audited for compliance with the
HIPAA Rules91
or an EHR Incentive Program.
Step 3: Review Existing Security of ePHI (Perform Security Risk Analysis)
The risk analysis process assesses potential threats and vulnerabilities to the confidentiality, integrity,
and availability of ePHI. The findings from this analysis inform your risk mitigation strategy.
Before you start, these recommended resources can provide guidance on your security risk analysis:
• OCR’s Guidance on Risk Analysis Requirements under the HIPAA Security Rule92
• OCR Security Rule Frequently Asked Questions (FAQs)93
• SRA Tool,94
which helps small practices conduct an extensive, systematic risk analysis
• National Institute of Standards and Technology (NIST) HIPAA Security Rule Toolkit95
If you want additional support, a security risk professional can plan and implement this analysis, but you
will need to oversee the process. Some commercial security risk analysis products are available, but
before you buy, seek out an independent review from a health information security expert.
Your first comprehensive security risk
analysis should follow a systematic
approach that covers all security
risks. It should:
• Identify where ePHI exists
in your practice and how
it is created, received,
maintained, and transmitted,
including in your EHR.
Types of risks to the ePHI
maintained in your EHR will
vary depending on whether
your EHR is based in your
office or hosted on the Internet (e.g., cloud-based or Application Service Provider).
• Identify potential threats and vulnerabilities to ePHI. Potential threats include human threats,
such as cyber-attack, theft, or workforce member error; natural threats, such as earthquake,
91
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/index.html
92
http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf
93
http://www.hhs.gov/ocr/privacy/hipaa/faq/securityrule/index.html
94
http://www.healthit.gov/providers-professionals/security-risk-assessment-tool
95
http://scap.nist.gov/hipaa/
Tips for a Better Security Risk Analysis
• Educate staff about the iterative and ongoing
nature of the security risk analysis process.
• Make security a high priority in your
workplace culture.
• Have an action plan that clearly assigns
responsibilities for each risk analysis
•
component.
Involve your EHR developer in the process.
• Ensure that the risk analysis is specific to
your situation.

Guide to
fire, or tornado; and environmental threats, such as pollution or power loss. Vulnerabilities are
flaws or weaknesses that if exploited by a threat could result in a security incident or a violation
of policies and procedures.
• Identify risks and their associated levels (e.g., high, medium, low). This is done by assessing the
likelihood that threats will exploit vulnerabilities under the safeguards currently in place and by
assessing the potential impacts to confidentiality, integrity, and availability of ePHI.
A risk analysis can produce results that may fall into “gray” areas. However, you will be able to see
where you are meeting, not meeting, or exceeding HIPAA requirements at a given point in time.
Security Risks in Office-Based EHRs vs. Internet-Hosted EHRs
All types of EHRs outperform paper medical records when it comes to providing better access to and use
of ePHI. On the other hand, EHRs also introduce new risks to ePHI. The mix of security risks is affected,
in part, by the type of EHR hosting you have: office-based (local host) or Internet-hosted (remote host).
Table 2 offers a few examples of different risks associated with office-based vs. Internet-hosted EHRs.

Guide to
Table 2: Examples of Potential Information Security Risks with Different Types of EHR Hosts
Host Type Risk Examples of Mitigation Steps
Office-Based EHRs Natural disaster could greatly disrupt the
availability of, and even destroy, ePHI.
Always store routine backups offsite.
Office-Based EHRs You directly control the security settings. Regardless of your practice size, follow
best practices on policies and procedures
about access to ePHI. For example,
use password controls and automatic
logout features.
Office-Based EHRs The security features on your office-
based EHR may not be as up-to-date and
sophisticated as an Internet-hosted EHR.
Maintain ongoing communication with
your EHR developer about new features
and their criticality to the security of
the EHR.
Office-Based EHRs When public and private information
security requirements change, you have
to figure out how to update your EHR
and work out any bugs.
Routinely monitor for changes in federal,
state, or private-sector information
security requirements and adjust settings
as needed.
Internet-Hosted
(Cloud-Based)
EHRs
You are more dependent on the
reliability of your Internet connection.
Your data may be stored outside the
U.S., and other countries may have
different health information privacy
and security laws that may apply to such
offshore data.
Confirm that your EHR host follows U.S.
security standards and requirements.
Internet-Hosted
(Cloud-Based)
EHRs
The developer may control many
security settings.
The adequacy of these settings may
be hard to assess, but ask for
specific information.
Internet-Hosted
(Cloud-Based)
EHRs
In the future, the developer might
request extra fees to update your EHR
for compliance as federal, state, and
private-sector information security
requirements evolve.
Ensure your EHR stays compliant. Before
you buy, it is OK to ask your developer
about fees it may charge for security
updates.
Step 4: Develop an Action Plan
Using the results from your risk analysis, discuss and develop an action plan to mitigate the identified
risks. Your action plan is informed by your risk analysis and should focus on high priority threats and
vulnerabilities. Take advantage of the flexibility that the HIPAA Security Rule provides, which allows you
to achieve compliance while taking into account the characteristics of your organization and its

Guide to
environment. It is important that your security plan is feasible and affordable for your practice. Often,
basic security measures can be highly effective and affordable (see box below).
Action Plan Components
The plan should have five
components:
• Administrative safeguards
• Physical safeguards
• Technical safeguards
• Organizational standards
• Policies and procedures
These components correspond with
the security components specified
in the table on the next page.
Table 3 briefly outlines each
component and provides examples.
Low-Cost, Highly Effective Safeguards
• Say “no” to staff requests to take home
laptops containing unencrypted ePHI.
• Remove hard drives from old computers
before you get rid of them.
• Do not email ePHI unless you know the data
is encrypted.
• Make sure your server is in a room accessible
only to authorized staff, and keep the
door locked.
• Make sure the entire office understands
that passwords should not be shared or easy
•
to guess.
Notify your office staff that you are required
to monitor their access randomly.
• Maintain a working fire extinguisher in case
of fire.
• Check your EHR server often for viruses
and malware.

Guide to
Table 3: Five Security Components for Risk Management
Security
Component
Examples of Vulnerabilities
Examples of Security
Mitigation Strategies
Administrative
Safeguards
• No security officer is designated.
• Workforce is not trained or is unaware
of privacy and security issues.
• Periodic security assessment and
reassessment are not performed.
• Security officer is designated
and publicized.
• Workforce training begins at hire
and is conducted on a regular and
frequent basis.
• Security risk analysis is performed
periodically and when a change occurs
in the practice or the technology.
Physical
Safeguards
• Facility has insufficient locks and other
barriers to patient data access.
• Computer equipment is easily
accessible by the public.
• Portable devices are not tracked or not
locked up when not in use.
• Building alarm systems are installed.
• Offices are locked.
• Screens are shielded from
secondary viewers.
Technical
Safeguards
• Poor controls allow inappropriate
access to EHR.
• Audit logs are not used enough to
monitor users and other EHR activities.
• No measures are in place to keep
electronic patient data from
improper changes.
• No contingency plan exists.
• Electronic exchanges of patient
information are not encrypted or
otherwise secured.
• Secure user IDs, passwords, and
appropriate role-based access
are used.
• Routine audits of access and changes
to EHR are conducted.
• Anti-hacking and anti-malware
software is installed.
• Contingency plans and data backup
plans are in place.
• Data is encrypted.
Organizational
Standards
• No breach notification and associated
policies exist.
• Business Associate (BA) agreements
have not been updated in several years.
• Regular reviews of agreements
are conducted and updates
made accordingly.
Policies and
Procedures
• Generic written policies and procedures
to ensure HIPAA security compliance
were purchased but not followed.
• The manager performs ad hoc
security measures.
• Written policies and procedures are
implemented and staff is trained.
• Security team conducts monthly
review of user activities.
• Routine updates are made to
document security measures.
For any single risk, a combination of safeguards may be necessary because there are multiple potential
vulnerabilities. For example, ensuring appropriate and continuous access to patient information may
require something as simple as a physical safeguard of adding a power surge protection strip, putting
the server in a locked room, and being meticulous about backups. Your action plan should have multiple
combinations of the five required components. Although the steps are sequential, the security
components are interrelated.

Guide to
Learn more about these requirements through the HIPAA Security Rule Educational Paper Series,96
the
ONC Cybersecurity web pages,97
and the Cybersecure training games.98
Process for Developing the Plan
Your security officer (see Step 1A) will need to
convene the team to develop the security
action plan. Begin by identifying the simple
actions that can reduce the greatest risks.
If your staff is unsure how specific HIPAA
requirements might apply to your specific
practice, review OCR Security Rule Guidance99
or other materials on ONC’s Health IT Privacy
and Security Resources web page.100
Ask your
security risk professional or legal counsel for
help as needed.
Once the plan is written, your designated
security team should meet periodically to
coordinate actions, work through unexpected
snags, and track progress. Reward your team
as it achieves milestones. Understand that you
will not be able to eliminate risk, but you will
be able to lower it by implementing
safeguards that reduce risk and
vulnerabilities. More about implementing
the action plan is in Step 5 below.
Step 5: Manage and Mitigate Risks
Once you have an action plan, follow it to
reduce security risks and better protect ePHI.
This step has four parts, each of which is
discussed below.
96
97
http://www.healthit.gov/providers-professionals/cybersecurity-shared-responsibility
98
99
100
Key Questions to Ask as You Plan
Who has keys to your practice?
Establish and follow a policy regarding keys
and passwords. Ensure that access keys are
returned before employees or contractors
leave your practice. If any former employees
and contractors have keys, change the locks.
Do not forget about “virtual” keys like
administrator accounts to your EHR or
database — be sure to change these
passwords periodically.
Where, when, and how often do you
back up? Do you have at least one
backup kept offsite? Can your data
be recovered from the backups?
Periodically test your backup system to
confirm you can retrieve your data backups
when needed.
What is your contingency/
disaster plan when/if your
server crashes and you cannot
directly recover data?
Always maintain developer documentation
that provides contact information and the
serial numbers of your server and other
hardware and software used, etc. Keep one
copy offsite in a secure place.

Guide to
5A. Implement Your Action Plan (which includes using applicable EHR security settings and
updating your HIPAA-related policies and procedures)
5B. Prevent Breaches by Educating and Training Your Workforce
5C. Communicate with Patients
5D. Update Your BA Contracts
Throughout this process, continue your efforts to build a culture that values patients’ health information
and actively protects it. One easy way is to give your staff time to play ONC’s Cybersecure training
games.101
The games are a fun and engaging way to provide answers to many of the everyday questions
around safeguarding PHI.
Step 5A: Implement Your Action Plan
The goal of following your security risk action plan is to protect patient ePHI through ongoing efforts to
identify, assess, and manage risks. As discussed in Step 4, your action plan, regardless of how it is
organized, should address all five HIPAA security components:
• Administrative safeguards
• Physical safeguards
• Technical safeguards
• Organizational standards
• Policies and procedures
This section focuses on technical safeguards and policies and procedures. Chapter 4 and Chapter 6
(Steps 1, 4, and 5D) provide additional information about these five components.
Information Security Settings in Your EHR
If an EHR is certified,102
it has a package of core technical security functions, such as the ability to
authenticate users with valid accounts. However:
• Use of CEHRT does not mean that your practice is “HIPAA compliant.”
• Certification does not guarantee performance or reliability of security functions in CEHRT,
especially if you turn off functions that are important to Privacy and Security Rule compliance.
• The security functions of the CEHRT may be “off,” or the settings could be at a suboptimal level
— both can create vulnerabilities.
101
102
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Certification.html

Guide to
It is vital that your practice learns about the
security settings in your EHR, and your assigned
EHR administrator(s) must have access to these
settings. Your Health Information Exchange
(HIE) may have specific requirements for
security settings.
Your risk analysis should specifically examine
the adequacy of your EHR security safeguards
as your system transmits, stores, and allows
modifications to ePHI.
Need assistance with appropriately configuring
your EHR security features? In addition to working with an information security expert, gather
information from sources such as:
• ONC’s Health IT Privacy and Security Resources web page103
• Your EHR developer
• Your state or county medical association
Written Policies and Procedures
With respect to protecting patient information, your policies and procedures guide how your practice
operates on a day-to-day basis. Your medical practice policies and procedures should accomplish the
following, at minimum:
• Establish protocols for all five security components (administrative, physical, and technical
safeguards; organizational standards; and policies and procedures).
• Commit to a HIPAA training program for all new staff when they are hired and on a regular basis
for the entire workforce.
• Instruct your workforce on what to do when something happens that impairs the availability,
integrity, or confidentiality of ePHI. (Sometimes these instructions are labeled as “incident
response” or “breach notification and management” plans.)
• Specify a sanction policy for violations of the Privacy, Security, or Breach Notification Rules or
your policies and procedures. Your sanction policy must be applied consistently as written.
• Detail enforcement, starting with the use of your EHR security audit logs to monitor access, use,
and disclosure of ePHI.
• Specify the need for written agreements with BAs that detail their specific responsibility to
comply with privacy and security.
103
Information Security: Encryption
Per the HIPAA Security Rule, a CE, such as a
health care provider, must use encryption
if, after implementing its security
management process, it determines that
encryption is a reasonable and appropriate
safeguard in its practice environment to
safeguard the confidentiality, integrity, and
availability of ePHI.

Guide to
As you make the updates, retain outdated policies and procedures in your security
documentation folder as described in Step 2.
Once your written policies and procedures are in place, the HIPAA Rules require that you
do the following:
• Train your workforce (see Step 5B) on what is required and how to implement the policies and
procedures. HIPAA requires that your workforce be specifically trained on these policies and
procedures, including breach notification. Your workforce will need periodic refresher training
on new aspects of your security program.
• Confirm that you have identified all your BAs. Contact them and confirm through written
agreements that they understand their responsibilities to carry out HIPAA Rules requirements
and to inform you of any breaches.
• Consistently apply your policies and procedures when unauthorized access to PHI occurs.
Whenever a member of your workforce does not comply with your policies and procedures, he
or she must be sanctioned. You must have a sanctions policy in place to ensure all members of
the workforce are treated fairly. Document your actions.
• Periodically review your policies and procedures to make sure they are current and your
practice adheres to them.
• Update your policies and procedures when changes in your internal or external environment
create new risks.
• Retain policies and procedures in your documentation folder for at least six years after you have
updated or replaced them (see Step 2). State and private-sector requirements may specify a
longer time period for retention.
Step 5B: Prevent Breaches by Educating and Training Your Workforce
Workforce education and training — plus a culture that values patients’ privacy — are a necessary part
of risk management. All of your workforce members — employees, volunteers, trainees, and contractors
supporting your office — need to know how to safeguard patient information in your practice. Your
training program should prepare your workforce to carry out:
• Their roles and responsibilities in safeguarding patients’ health information and complying with
the HIPAA Rules
• Your HIPAA-related policies
• Your procedures, including processes to monitor security and steps for breach notifications

Guide to
Your workforce may need focused
training to develop the requisite
skills to perform the steps you
require. ONC’s Cybersecure
training games104
and mobile
device training videos105
are
highly recommended resources.
Reinforce workforce training with
reminders. Above all, lead by
example by adhering to your
policies and procedures.
Frequency of Workforce Training
Your practice must educate and
train individual workforce
members at the time each person is hired or contracted. Industry best practices suggest that the entire
workforce should be trained at least once every year and any time your practice changes its policies or
procedures, systems, location, infrastructure, etc. It is particularly important that your workforce be
trained on how to respond immediately to any potential security incidents or an unauthorized disclosure
of ePHI because these situations may be breaches.
Making Protecting Patient Information Part of Your Routine
Deliberately create a culture that emphasizes PHI confidentiality. You can do this in a number of ways,
which include:
• Speaking often about the importance of trust in the patient-provider relationship. Remind your
workforce that patients expect your practice to be a good steward of their health information.
• Continually reminding staff to safeguard patient confidentiality and the security of ePHI.
• Making sure your staff has a copy of your policies and procedures for easy reference. Remind
them to comply with those policies and procedures.
• Addressing staff questions, and getting outside resources to help if you feel you need additional
expertise with message delivery.
• Reassessing each workforce member’s job functions and enabling him/her to access only the
minimum necessary health information as appropriate.
Step 5C: Communicate with Patients
Your patients may be concerned about the confidentiality and security of their health information in an
EHR. Don’t wait for them to ask. Instead, provide them with information about EHRs, especially the
104
105
http://www.healthit.gov/providers-professionals/worried-about-using-mobile-device-work-heres-what-do-video

Guide to
benefits EHRs can bring to them as patients. Reassure patients that you have a system to proactively
protect the privacy and security of their health information. Your staff should be able to speak to the
confidentiality and security of your EHR as well.
To preserve good patient relations, follow your policies and procedures for communicating with patients
and caregivers if a breachof unencrypted ePHI ever occurs. As explained in Chapter 7, OCR and most
state attorneys general strictly enforce breach procedures.
A multi-faceted communications plan will help you avert patient concerns about EHRs and privacy.
• Inform patients that you place a priority on maintaining the security and confidentiality of their
health information. ONC and other federal agencies have developed consumer education
handouts106
that you may want to use or adapt.
• Address patients’ individual health information rights, which include the right to access or
obtain a copy of their electronic health record in an electronic form.
• Educate patients about how their health information is used and may be shared outside your
practice. In some cases, depending on state law and the nature of information you are sharing,
you may need to obtain a patient’s permission (consent or authorization) prior to exchanging
his/her health information.
• Notify affected patients and caregivers when a breach of unsecured PHI has occurred, in
accordance with your updated policies and procedures.
Patient relations on security issues should be an integral part of your overall patient engagement
strategy.107
Consumer communications should be culturally appropriate. Consider the various languages,
communication needs, and trust levels of different patient populations. If a particular group has some
distrust of the medical establishment, take extra steps to reassure them that you are safeguarding
their information.
Be prepared to discuss and answer the questions that concerned patients and their caregivers may have.
For ideas, visit the ONC Health IT Privacy and Security Resources web page,108
which provides other
materials for you and your patients.
106
107
http://www.healthit.gov/patients-families/protecting-your-privacy-security and
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/provider_ffg.pdf
108

Guide to
Fulfill Your Responsibilities for Patients’ Health Information Rights109
In the future, expect more patients to ask how you handle their electronic health information. More
patients will ask for their medical records, and some will want changes made in their records. As part of
the HIPAA Rules and Stage 2 Meaningful Use, you must respond to these patient requests. In particular:
• Patients can request copies of and access to their PHI in paper or electronic format, including
from your EHR. Meaningful Use Core Objectives indicate that such ePHI held in the EHR should
be made available to patients, upon request, within four business days of it being available to
the provider (see Chapter 3).
• Patients can request corrections and amendments to the PHI in their records; this is called a
“right to amend” and has always been part of the HIPAA Rules. Now Stage 2 Meaningful Use
Objective 9 requires you to respond to patients’ requests to amend their ePHI that is in
your EHR.
• Under the Privacy Rule, a patient, or another person on a patient’s behalf, can ask his/her
provider to restrict submission of his/her PHI to the patient’s health plan when the patient has
paid in full for the health care service or item — and the provider must honor that request.
To prepare for patient requests, ask your EHR
developer about ways to use your system to help you
fulfill individual patient rights. For example, confirm
what EHR capabilities are currently available and
when additional capabilities will be available (such as
amendments to and copies of their ePHI). Your
developer or other expert consultant may also be able
to assist you in implementing these features both in
your EHR and your practice workflow. Ask your EHR
developer to provide step-by-step instructions or best
practice guidelines that include screen shots on how
to perform these actions.
Once you have established a process and procedure on how to provide patients with a copy of their
medical information from your EHR, develop an understanding of and procedures for what to do when
patients ask you to modify or to amend their health information, restrict disclosure, or obtain a report
about prior disclosures. (See Chapter 2.)
Online Communications with Patients
If you plan to interact with patients via online platforms (e.g., email, texting, a patient portal for your
EHR, or social media), you must meet the Security Rule and Meaningful Use standards for the secure
messaging of ePHI.
109
OCR’s patient access memo may be a helpful resource regarding patients’ health information rights:
http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/righttoaccessmemo.pdf

Guide to
Remember that a provider who is emailing and texting patients and/or other providers is creating a
security risk for the ePHI unless the transmission is encrypted. See the sidebar “Email and Texting” in
Chapter 4 and visit the ONC website for information about the risks of emailing via mobile devices110
and texting health information.111
Read the Stage 2 EP Meaningful Use Core and Menu Measures Table
of Contents.112
If you have continued questions, obtain guidance from appropriate legal counsel.
Step 5D: Update Your BA Contracts
Be sure to update all your BA agreements to comply with the HIPAA Privacy, Security, and Breach
Notification Rules.113
(Refer to Chapter 2 for a refresher on the definition of a BA.) Such agreements
should require your BAs to:
• Fully comply with relevant
safeguards for PHI that they get
from your practice
• Train their workforce
• Adhere to additional requirements for
patient rights and breach notification
OCR offers sample BA contract provisions.114
Step 6: Attest for Meaningful Use Security-Related Objective
The EHR Incentive Programs provide incentive payments to EPs as they demonstrate adoption,
implementation, upgrading, and meaningful use of CEHRT. These Meaningful Use Programs are
designed to support providers with the health information technology (health IT) transition and instill
the use of EHRs to improve the quality, safety, and efficiency of patient health care.
Providers can register for the EHR Incentive Programs115
anytime, but attesting requires you to have
met the Meaningful Use requirements for an EHR reporting period. So, only attest for an EHR Incentive
Program after you have fulfilled the security risk analysis requirement and have documented
your efforts. Specifically, you should not attest until you have conducted your security risk analysis
(or reassessment) and corrected any deficiencies identified during the risk analysis. Document
these changes.
110
http://www.healthit.gov/providers-professionals/faqs/can-you-use-email-send-health-information-using-your-mobile-device
111
http://www.healthit.gov/providers-professionals/faqs/can-you-use-texting-communicate-health-information-even-if-it-another-p
112
http://www.cms.gov/Regulations-and-
Guidance/Legislation/EHRIncentivePrograms/Downloads/Stage2_MeaningfulUseSpecSheet_TableContents_EPs.pdf
113
Modifications to the Rules expand the types of entities considered BAs and place more obligations on BAs to strictly follow the
HIPAA Security Rule.
114
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html
115
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/RegistrationandAttestation.html
Developers Supporting Health
Information Exchange Are
Often Considered BAs
Developers that support your practices
through cloud computing/storage or
secure physical storage facilities are most
likely among your practice’s BAs.

Guide to
When you attest116
to Meaningful Use, it is a legal statement that you have met specific standards,
including that you protect electronic health information. Providers participating in the EHR Incentive
Programs can be audited.
If you attest prior to actually meeting the Meaningful Use security requirement, it is possible you could
increase your business liability for violating federal law and making a false claim. Consult with
appropriate legal counsel for further guidance. From this perspective, consider implementing
multiple security measures prior to attesting. The priority would be to mitigate high-impact and
high-likelihood risks.
Step 7: Monitor, Audit, and Update Security on an Ongoing Basis
Step 7 relates to the HIPAA Security Rule requirements that you have audit controls in place and
have the capability to audit. HIPAA uses the term “audit” in two ways. In the first context, audit
is what you do to monitor the adequacy and effectiveness of your security infrastructure and
make needed changes.
• Have your security officer, IT administrator, and EHR developer work together so your system’s
monitoring/audit functions are active and configured to your needs. They may want you to:
o Decide whether you will conduct the audits in-house, use an information security
consultant, or have a combination of the two
o Determine what to audit and how the audit process will occur
o Identify trigger indicators — or signs that ePHI could have been compromised and
further investigation is needed
o Establish a schedule for routine audits and guidelines for random audits
In the second context, audit refers to an effort to examine what happened. This means your EHR must
be set up to maintain retrospective documentation (i.e., an “audit log”) on who, what, when, where, and
how your patients’ ePHI has been accessed. Such audits (i.e., the auditing process, which would examine
logs) are required security technical capabilities that would be part of your Stage 1 and 2 Meaningful
Use demonstrations. These capabilities include auditable events and tamper resistance, audit logs,
access control and authorizations, automatic logoff, and emergency access (see Stage 2 Meaningful Use
Core Measure 9117
for more description).
Your audit controls and capabilities should be scaled to your practice’s size. For example, your certified
EHR has a function to generate audit logs. This means it can record when, where (e.g., which laptop),
and how ePHI is accessed; by whom; what the individual did; and for what purposes. Your EHR can then
produce reports using these data. Such audit logs are useful tools for both holding your workforce
116
http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/RegistrationandAttestation.html
117
http://www.cms.gov/Regulations-and-
Guidance/Legislation/EHRIncentivePrograms/downloads/Stage2_EPCore_9_ProtectElectronicHealthInfo.pdf

Guide to
accountable for protecting ePHI and for learning about unexpected or improper modifications to
patient information.
Medical Record Retention
As you know, state law requires you to store medical records for a specified number of years. Your
obligations and the length of time to maintain patient medical records recorded in an EHR are usually
also a matter of your state’s medical record retention laws. These laws are often found in a state’s
licensing laws.
If one of your BAs is an HIE, your written
agreement with the HIE should require it
to return or securely dispose of the ePHI it
creates, receives, maintains, or transmits
on behalf of your practice (the CE).
This Guide is not intended to serve as legal
advice or as recommendations based on a
provider or professional’s specific
circumstances. We encourage providers
and professionals to seek expert advice

Guide to
Chapter 7
Breach Notification, HIPAA Enforcement, and Other
Laws and Requirements
Covered Entities (CEs) and Business Associates (BAs)
that fail to comply with Health Insurance Portability
and Accountability Act (HIPAA) Rules can receive
civil and criminal penalties.
Civil Penalties
The Office for Civil Rights (OCR) is able to impose
civil penalties for organizations that fail to comply
with the HIPAA Rules. The potential civil penalties
are substantial. Your good faith effort to be in
compliance with the HIPAA Rules is essential.
State attorneys general also may bring civil actions
and obtain damages on behalf of state residents for
violations of the HIPAA Rules.118
Learn more about
OCR’s HIPAA enforcement;119
HIPAA Privacy,
Security, and Breach Notification Audit Program;120
and HIPAA Enforcement Rule.121
Criminal Penalties
The U.S. Department of Justice investigates and
prosecutes criminal violations of HIPAA. Under
HIPAA, the Justice Department can impose criminal
penalties for:
118
This authority was granted to state attorneys general in the Health Information Technology for Economic and Clinical Health
(HITECH) Act.
119
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/index.html
120
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/index.html
121
http://www.hhs.gov/ocr/privacy/hipaa/administrative/enforcementrule/index.html
Oversight
OCR, within the U.S. Department of Health
and Human Services (HHS), administers and
enforces the HIPAA Privacy, Security, and
Breach Notification Rules. OCR conducts
complaint investigations, compliance
reviews, and audits. OCR may impose
penalties for failure to comply with the
HIPAA Rules.
The Centers for Medicare and Medicaid
Services (CMS) within HHS oversees the
Medicare and Medicaid Electronic Health
Record (EHR) Incentive Programs.
The Office of the National Coordinator for
Health Information Technology (ONC)
provides support for the adoption and
promotion of health information technology
(health IT) and Health Information
Exchanges (HIEs) to improve health care
in the United States.

Guide to
• Knowing misuse of unique health identifiers122
• Knowing and unpermitted acquisition or disclosure of Protected Health Information (PHI)123
The Breach Notification Rule: What to Do If You Have a Breach
A breach is, generally, an impermissible use or disclosure under the Privacy Rule that compromises the
security or privacy of PHI. An impermissible use or disclosure of unsecured PHI is presumed to be a
breach unless the CE or BA demonstrates (based on a risk assessment) that there is a low probability
that the PHI has been compromised.124
When a breach of unsecured PHI occurs, the Rules require your
practice to notify affected individuals, the Secretary of HHS, and, in some cases, the media.125
The Breach Notification Rule requires HIPAA CEs to notify individuals and the Secretary of HHS
of the loss, theft, or certain other impermissible uses or disclosures of unsecured PHI. In
particular, health care providers must promptly notify the Secretary of HHS if there is any
breach of unsecured PHI that affects 500 or more individuals, and they must notify the media if
the breach affects more than 500 residents of a state or jurisdiction. If a breach affects fewer
than 500 individuals, the CE must notify the Secretary and affected individuals. Reports of
breaches affecting fewer than 500 individuals are due to the Secretary no later than 60 days
after the end of the calendar year in which the breaches occurred.
• Significant breaches are investigated by OCR, and penalties may be imposed for failure
to comply with the HIPAA Rules. Breaches that affect 500 or more patients are publicly
reported on the OCR website.126
• Similar breach notification provisions implemented and enforced by the Federal Trade
Commission apply to Personal Health Record (PHR) developers and their third-party
service providers.
If you can demonstrate through a risk assessment that there is a low probability that the use or
disclosure compromised unsecured PHI, then breach notification is not necessary. (Please note that this
breach-related risk assessment is different from the periodic security risk analysis required by the
Security Rule).
And, if you encrypt your data in accordance with the OCR guidance regarding rendering data unusable,
unreadable, or indecipherable, you may avoid reporting what would otherwise have been a reportable
122
HIPAA regulations specify the appropriate use of identifiers.
123
The HIPAA Privacy Rule establishes what is an impermissible obtainment or disclosure of PHI.
124
http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf
125
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/index.html
126
https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf

Guide to
breach. Remember, encryption depends on the encryption key being kept highly confidential, so do not
store it with the data or in a location that would compromise it.127
Table 4 compares secured and unsecured PHI.
Table 4: Comparison of Secured and Unsecured PHI
Secured PHI Unsecured PHI
An unauthorized person cannot use, read, or
decipher any PHI that he/she obtains because your
practice:
• Encrypts the information; or
• Clears, purges, or destroys media (e.g., data
storage devices, film, laptops) that stored or
recorded PHI;
• Shreds or otherwise destroys paper PHI.
(These operations must meet applicable
federal standards.128
)
An unauthorized person may use, read, and decipher
PHI that he/she obtains because your practice:
• Does not encrypt or destroy the PHI; or
• Encrypts PHI, but the decryption key has also
been breached.
Risk Assessment Process for Breaches
When you suspect a breach of unsecured PHI has occurred, first conduct a risk assessment129
in order to
examine the likelihood that the PHI has been compromised. For you to demonstrate that a breach has
not compromised PHI, your practice must conduct the risk assessment in good faith and by thoroughly
assessing at least the four required elements130
listed below.
• The nature and extent of the PHI involved in the use or disclosure, including the types of
identifiers and the likelihood that PHI could be re-identified
o As noted above, if your practice has a breach of encrypted data — and if you had
followed standard encryption specifications — it would not be considered a breach of
unsecured data, and you would not have to report it.
• The unauthorized person who used the PHI or to whom the disclosure was made (e.g., a sibling
or a journalist)
127
Federal Register (FR). (24 August, 2009). Rules and Regulations. II.A. Guidance Specifying the Technologies and
Methodologies That Render Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals
(Vol. 74, No. 162). Paragraph 3, pp. 42741-42.
128
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brguidance.html
129
45 Code of Federal Regulations (CFR) 164.402(2); http://www.ecfr.gov/cgi-bin/text-
idx?SID=938e08839465e82e2c30c3bd4a359ce2&node=pt45.1.164&rgn=div5#se45.1.164_1402
130
The four elements are taken from the “Definition of Breach” section at
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/.

Guide to
• The likelihood that any PHI was actually acquired or viewed (e.g., an audit trail would
provide insights)
• The extent to which the risk to the PHI has been mitigated (e.g., promptly changed
encryption key)
When performing this assessment, you should address each element separately and then analyze
the combined four elements to determine the overall probability that PHI has been compromised.
The conclusions from your assessment must be reasonable. You have the burden of demonstrating
that a use or disclosure of unsecured PHI did not constitute a breach. If this assessment indicates that
there is:
• Low probability of
compromised PHI,
then the use or
disclosure is not
considered to be a
breach and no
notification is
necessary.
• Probability of
compromised PHI,
breach notification is
required.
Reporting Breaches
If you choose not to conduct the risk assessment, or if, after performing the risk assessment outlined
above, you determine that breach notification is required, there are three types of notification to be
made to individuals, to the Secretary of HHS, and, in some cases, to the media. The number of
individuals that are affected by the breach of unsecured PHI determines your notification requirements.
Visit the OCR Breach Notification Rule web page131
for more information on notifying individuals, the
Secretary, and the media.
If you determine that breach notification is required, you should also visit the OCR website for
instructions132
on how to submit the breach notification form133
to the Secretary of HHS. Once notified,
HHS publicly reports, on the OCR website,134
breaches that affect 500 or more individuals. OCR opens a
compliance review of all reported breaches that affect 500 or more individuals and many breaches
affecting fewer than 500. (Note that similar breach notification provisions, which are implemented and
131
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/
132
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brinstruction.html
133
http://www.hhs.gov/ocr/privacy/hipaa/administrative/breachnotificationrule/brinstruction.html
134
http://www.hhs.gov/ocr/privacy/hipaa/enforcement/index.html

Guide to
enforced by the Federal Trade Commission,135
apply to developers of PHRs that are not providing this
service for a CE.)
Investigation and Enforcement of Potential HIPAA Rules Violations
OCR initiates investigations upon receipt of complaints,136
breach reports, information provided by other
agencies, and the media. The HIPAA Enforcement Rule provides different penalties for each of four
levels of culpability:
• Violations that the entity did not know about and would not have known about by exercising
reasonable diligence
• Violations due to “reasonable cause”
• Violations due to “willful neglect” that are corrected within 30 days
• Violations due to “willful neglect” that are not corrected within 30 days137
Penalties for Violations
Table 5 provides an overview of the penalty amounts for HIPAA violations. Contact your legal counsel for
specific guidance.
Table 5: Overview of Penalties
Intent
Minimum Per
Incident
Annual Cap for
All Violations
Did Not Know or Could Not Have Known $100 – $50,000 $1.5 million
Reasonable Cause and Not Willful Neglect $1,000 – $50,000 $1.5 million
Willful Neglect, but Corrected Within 30 Days $10,000 – $50,000 $1.5 million
Willful Neglect and Not Corrected Within 30 Days $50,000 $1.5 million
In addition to investigations that OCR conducts for potential violations of the HIPAA Rules, the HITECH
Act authorizes and requires HHS to conduct periodic audits to ensure that CEs and BAs comply with the
HIPAA Rules.138
Audits are not initiated because of any particular event or incident, but rather due to
application of a set of objective criteria. HHS uses these audits as a way to examine mechanisms for
compliance, identify best practices, and discover risks and vulnerabilities that may not have come to
light through OCR’s ongoing complaint investigations and compliance reviews.
135
http://www.consumer.ftc.gov/
136
http://www.hhs.gov/ocr/privacy/hipaa/complaints/
137
45 CFR 160.404.
138
HITECH Act, Section 13411.

Guide to
Other Laws and Requirements
Besides HIPAA Rules, HITECH, and Meaningful Use privacy- and security-related requirements, your
medical practice may also need to comply with additional privacy and security laws and requirements.
Table 6 provides a snapshot of these domains. Your state, state board of medicine, state associations,
Regional Extension Center (REC), and HIE initiatives also may have guidance.
Table 6: Overview of Other Laws and Requirements
Laws/
Requirements
Key Points
Sensitive Health
Information
• Some laws and frameworks recognize that particular health conditions may put
individuals at a higher risk for discrimination or harm based on that condition. Federal
and some state laws require special treatment and handling of information relating to
alcohol and drug abuse, genetics, domestic violence, mental health, and Human
Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS).
• Applicable federal laws:
o 42 CFR Part 2: Confidentiality of Alcohol and Drug Abuse
o Family Educational Rights and Privacy Act (FERPA)
o Title X of Public Health Service Act — Confidentiality
Adolescent/Minors’
Health Information
• State and federal laws generally authorize parent or guardian access.
• Depending on age and health condition (e.g., reproductive health, child abuse, mental
health) and applicable state law, minors also have privacy protections related to their
ability to consent for certain services under federal or state law.
• Applicable federal laws:
o FERPA
o Genetic Information Nondiscrimination Act (GINA)
o Title X of Public Health Service Act
Note: The HIPAA Omnibus Rule clarified that CEs may release student immunization
records to schools without authorization if state law requires schools to have
immunization records and written or oral agreements (must be documented).
Private Sector A contracting health plan or payer may require additional confidentiality or safeguards.
A good place to start privacy- and security-related compliance implementation within your practice is to:
• Stay abreast of privacy and security updates. Sign up for OCR’s privacy and security listservs139
to
receive updates, and contact your local association to learn about available assistance sources.
• Integrate privacy and security updates into your policies and procedures.
• Identify and monitor violations and demonstrate good faith efforts to promptly cure any
violation that may occur.
139
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/listserv.html

Guide to
• Keep your workforce training materials up-to-date and conduct regular training sessions.
• Continually raise your practice’s level of awareness about how to minimize the
likelihood of privacy and security breaches.

ONC Privacy and Security Best Practices for HIPAA

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