Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know

Exceptions to
Information
Blocking Defined
in Proposed Rule:
Here’s What You
Need to Know

© 2018 Health Catalyst
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The Office of the National Coordinator for
Health Information Technology (ONC) recently
released a proposed rule to implement
provisions in the 21st Century Cures Act.
The Cures Act was signed into law in
December 2016 and introduced sweeping
healthcare legislation and funding for medical
research, drug development, and medical
device innovation.
The ONC’s long-awaited proposed rule
ushers in the next phase of the Cures Act
by adding substance to these provisions.
The Cures Act Becomes Law

The proposed rule was released in March 2019
and provides for a public comment period that
expires on June 3, 2019.
Following the public comment period, ONC will
review feedback and eventually release the final
rule, which could take another one to two years.
According to the U.S. Department of Health and
Human Services (HHS), the proposed rule:
…is designed to increase innovation and
competition by giving patients and their
healthcare providers secure access to
health information and new tools, allowing
for more choice in care and treatment.”

In its promotion of access, exchange, and
use of electronic health information (EHI),
the proposed rule outlines seven
exceptions to information blocking.
It’s important for healthcare providers,
healthcare systems, and vendors that
are interested in promoting information
sharing to review these exceptions
during the public comment period to
help ensure that they are sufficiently
restrictive in the final rule.

The introduction of the Health Information
Technology for Economic and Clinical Health
(HITECH) HITECH Act, provided federal subsidies
for the adoption of EHRs.
Although the legislation required that EHRs
have interoperability functionality, it was less
successful in promoting interoperability
in practice.
Further, the HITECH Act did not
anticipate the extent to which
widespread information blocking
practices would limit interoperability.

Now that most healthcare organizations have
adopted EHRs, much of this information is
siloed and can be difficult to get the right
information at the point of care.
Siloed information also inhibits the ability to
analyze data that can improve care delivery
and financial and operational processes.
The promise of vast amounts of health
information can’t be realized until
interoperability improves.

One reason better interoperability does not exist is
simply that it can be difficult to get different systems
to communicate with one another effectively.
However, this is also due to information
blocking practices. Information blocking
practices may be based on organizational
policy or they may be technical.

Examples of organizational policy are:
Taking the position that data
models or schemas are
proprietary, even though it has
been long established that
data compilations are not
protected by copyright or other
intellectual property laws.
Claiming that sharing EHI for
treatment with a third-party
provider is prohibited by
HIPAA, when it is not.

An example of technical information blocking
is not making application programming
interfaces (APIs) readily available.
Whether intentional or not, information
blocking practices can inhibit the sharing of
critical healthcare information, with a range
of negative consequences including:
• Failure to coordinate care.
• Unavailability of important clinical values
at the point of care.
• A lack of the rich data needed to fully
utilize analytic tools, benchmarking,
and machine learning techniques.

Following from the definition in the Cures Act, the
proposed rule defines information blocking as:
The Seven Proposed Exceptions to
Limiting Information Blocking
…a practice that, except as required by
law or covered by an exception…is likely
to interfere with, prevent, or materially
discourage access, exchange, or use of
electronic health information.”
The Cures Act stipulates fines for information
blocking up to $1,000,000 per violation.
The proposed rule includes seven proposed
exceptions to information blocking which, if the
required elements of the relevant exception are
met would exempt the practice from enforcement.

These seven exceptions are:
1. Preventing harm
2. Promoting the Privacy of EHI
3. Promoting the Security of EHI
4. Recovering Costs Reasonably Incurred
5. Responding to Request that are Infeasible
6. Licensing of Interoperability Elements on
Reasonable and Non-discriminatory Terms
7. Maintaining and Improving Health IT Performance

1: Preventing Harm
An organization may engage in a practice
that is reasonable and necessary to prevent
physical harm to a patient or other person.
The organization must have a reasonable
basis to believe that its practice will
directly and substantially reduce the
likelihood of harm to a patient.
The organization must have adopted a
policy that addresses patient harm or make
case by case findings that a disclosure of
EHI could result in patient harm.

2: Promoting the Privacy of EHI
An organization may engage in a
practice to protect the privacy of EHI.
The organization must demonstrate a
basis for its actions in HIPAA and
other privacy laws.

3: Promoting the Security of EHI
An organization may implement measures
to protect the security of EHI. The practices
must be narrowly tailored to the measures
necessary to protect security.

5: Responding to Request that are Infeasible
An organization is permitted to decline a
request for EHI access if it determines, using
objective and verifiable criteria consistently
applied, that the request is infeasible.

6: Licensing of Interoperability Elements on Reasonable and
Non-discriminatory Terms
An organization may claim that its technology
or processes are protected by IP law, however,
the organization has an obligation to offer a
license to the technology or processes on
reasonable and non-discriminatory terms.

7: Maintaining and Improving Health IT Performance
Allows for downtime that may make health IT
and EHI temporarily unavailable in order to
perform maintenance or upgrades.

A consistent theme that runs through the
exceptions that the organization’s practices
must be reasonable and non-discriminatory
and must be consistently applied.
Health Catalyst generally views each of
these exceptions to be well-defined and
sufficiently narrow.
However, there are some aspects of the
exceptions that should be modified to
ensure that there are no major loopholes
that would continue to encourage
information blocking practices.

Licensing of Interoperability Elements on Reasonable and
The Good
This exception addresses a problem that
many data and analytics vendors encounter
when working with some vendors or
healthcare providers.
When asked for access to a database, a
vendor or healthcare provider may claim
that providing access to data will infringe its
intellectual property rights.

Licensing of Interoperability Elements on Reasonable and
The Good
The exception would create an obligation for
the party receiving the request to respond to
the requestor within 10 business days, and to
offer a license to any technology or processes
on reasonable and non-discriminatory terms,
and at a reasonable cost.
The language on reasonable cost is helpful
because it could help to limit the practice of
vendors charging prohibitive fees for access.

An organization could use one or more of the
exceptions to justify information blocking
practices, and it could be difficult to challenge
this use of the exceptions.
These exceptions include:
Privacy and Security Exceptions
Responding to Requests That Are Infeasible
What to Watch Out For
>
>

These exceptions are drafted quite broadly.
A healthcare provider or vendor could claim
that it does not intend to share EHI in order
to comply with the HIPAA privacy or
security standards.
While the claim must be backed up, in
practice it may be very difficult to
challenge this position.

Attempts to “litigate” the issue, whether in
the figurative sense of challenging the basis
for an unreasonable determination, or filing
an information blocking complaint, may be
too time-consuming, costly, and ultimately
be ineffective.
There is also the possibility that an
organization would “comply” with the rule
by delivering low quality information to
providers, and this type of behavior could
also be difficult to challenge.

This is another exception that could be misused
because of its potentially broad scope.
The exception states:
…an actor must demonstrate that
complying with a request to access,
exchange, or use EHI would impose a
substantial burden on the actor that is
unreasonable under the circumstances.”

Although proving that a request poses a
substantial burden takes into account several
factors, such as:
• Cost to comply
• Type of information
• Financial resources
• Technical resources

These findings may prove very difficult to
challenge, opening the door to misuse and
continued information blocking.
One of these factors is that the party must
provide “comparable access,” but this could
open the door to providing access that on its
face appears comparable but in practice lacks
granularity, speed, or other attributes that
would make the EHI useful.
Reasonable cost provisions could be watered
down in the final rule and open the door for
continued prohibitive charges for access.

Overall, the proposed rule is a very
positive development for promoting
interoperability, with strong, narrowly
defined exceptions to limit information
blocking practices.
If the proposed rule is implemented
substantially in its current form, it
should reduce information blocking
and promote interoperability.
Why This Matters

However, there is still a risk that industry
groups will try to delay or dilute the
proposed rule.
The proposed rule has already been
delayed–more than two years–and it will
still take another one to two years for the
final rule to go into effect.
Healthcare providers, healthcare systems,
and healthcare IT vendors should all care
about this rule being implemented in
its strongest possible form.
Why This Matters

Reducing information blocking will help healthcare
providers and systems leverage technology and
services to improve processes and patient care,
and financial and operational processes.
It will help healthcare IT vendors by allowing
them to innovate in faster cycles to develop
and deploy those technologies and services.
Some vendors have profited from information
blocking and siloed data in order to gain
market share and increase the barrier of
entry to others, but these practices ultimately
harm the healthcare system and patient care.
Why This Matters

For more information:
“This book is a fantastic piece of work”
– Robert Lindeman MD, FAAP, Chief Physician Quality Officer

More about this topic
Link to original article for a more in-depth discussion.
Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know
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EHR Integration: Achieving this Digital Health Imperative
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Four Critical Phases for Effective Healthcare Data Governance
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Luke Skelley, Sales, VP; Matt Denison, Payer Solutions, VP; Rob McCrory, Strategic Advisor
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Jane Felmlee , Finance Operations Consultant

Other Clinical Quality Improvement Resources
Click to read additional information at www.healthcatalyst.com
Prior to joining Health Catalyst Dan Orenstein was at athenahealth, Inc. (NASDAQ: ATHN)
for 10 years, the last 7 as General Counsel and Secretary. Prior to that, Dan practiced in the
areas of corporate, intellectual property, and healthcare law with law firms in Boston and
Washington, D.C. He has written and presented on health care law and IT topics throughout
his career. He also served as a leader of the American Health Lawyers Association’s Health
IT practice group.
Daniel Orenstein, JD

Other Clinical Quality Improvement Resources
Click to read additional information at www.healthcatalyst.com
Health Catalyst is a mission-driven data warehousing, analytics and outcomes-improvement company
that helps healthcare organizations of all sizes improve clinical, financial, and operational outcomes
needed to improve population health and accountable care. Our proven enterprise data warehouse
(EDW) and analytics platform helps improve quality, add efficiency and lower costs in support of more
than 65 million patients for organizations ranging from the largest US health system to forward-thinking
physician practices.
Health Catalyst was recently named as the leader in the enterprise healthcare BI market in
improvement by KLAS, and has received numerous best-place-to work awards including Modern
Healthcare in 2013, 2014, and 2015, as well as other recognitions such as “Best Place to work for
Millenials, and a “Best Perks for Women.”

Exceptions to Information Blocking Defined in Proposed Rule: Here’s What You Need to Know

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