The	
  Basics	
  of	
  Protecting	
  PHI	
  
Best Practices when Working with Business Associates
Gelb, An Endeavor Management Company
1011 Highway 6 South P + 281.759.3600
Suite 120 F + 281.759.3607
Houston, Texas 77077 www.gelbconsulting.com	
  
The	
  Basics	
  of	
  Protecting	
  PHI	
  
	
  
©	
  2015	
  Gelb	
  Consulting.	
  All	
  Rights	
  Reserved.	
   	
   	
  
Page	
  2	
  
	
  
Note:	
  We	
  are	
  not	
  attorneys	
  and	
  this	
  represents	
  our	
  experience	
  in	
  working	
  with	
  
healthcare	
  organizations.	
  	
  This	
  should	
  not	
  be	
  considered	
  legal	
  advice.	
  	
  	
  
	
  
Overview	
  
The	
  Health	
  Insurance	
  Portability	
  and	
  Accountability	
  Act	
  (HIPAA)	
  placed	
  clear	
  responsibility	
  on	
  
healthcare	
  providers	
  to	
  protect	
  individually	
  identifiable	
  health	
  information.	
  Hospitals	
  and	
  
healthcare	
  professionals	
  who	
  work	
  with	
  this	
  type	
  of	
  information	
  everyday	
  are	
  familiar	
  with	
  HIPAA	
  
requirements.	
  However,	
  when	
  external	
  business	
  associates	
  are	
  engaged	
  for	
  activities	
  in	
  which	
  
protected	
  health	
  information	
  (PHI)	
  is	
  accessible	
  or	
  shared,	
  there	
  is	
  often	
  a	
  lack	
  of	
  explicit	
  discussion	
  
about	
  how	
  to	
  protect	
  PHI.	
  	
  
	
  
HIPPA	
  rules	
  stipulate	
  that	
  business	
  associates	
  are	
  directly	
  liable	
  for	
  following	
  HIPAA	
  requirements	
  
when	
  working	
  with	
  PHI.	
  For	
  this	
  reason,	
  healthcare	
  providers	
  are	
  required	
  to	
  employ	
  a	
  business	
  
associate	
  agreement	
  (BAA)	
  or	
  other	
  written	
  arrangement	
  that	
  specifies	
  how	
  the	
  business	
  associate	
  
will	
  comply	
  with	
  HIPAA.	
  Nevertheless,	
  business	
  associates	
  may	
  be	
  unaware	
  of	
  the	
  full	
  breadth	
  of	
  
regulations	
  or	
  lack	
  the	
  experience	
  and/or	
  resources	
  to	
  put	
  proper	
  safeguards	
  in	
  place.	
  In	
  fact,	
  
according	
  to	
  the	
  U.S.	
  Department	
  of	
  Health	
  &	
  Human	
  Services,	
  some	
  of	
  the	
  largest	
  HIPAA	
  breaches	
  
have	
  involved	
  business	
  associates.	
  From	
  Gelb’s	
  perspective	
  as	
  a	
  small	
  business	
  that	
  works	
  with	
  PHI,	
  
HIPAA	
  has	
  complex	
  guidelines	
  that	
  require	
  time	
  and	
  resources	
  to	
  fully	
  understand	
  and	
  ensure	
  
compliance.	
  
	
  
Privacy	
  violations	
  –	
  whether	
  the	
  fault	
  of	
  a	
  hospital	
  representative	
  or	
  a	
  business	
  associate	
  –	
  can	
  be	
  a	
  
public	
  relations	
  nightmare	
  and	
  violate	
  the	
  trust	
  of	
  the	
  community.	
  For	
  this	
  reason,	
  it	
  is	
  important	
  
for	
  hospitals	
  to	
  go	
  beyond	
  a	
  BAA	
  when	
  considering	
  HIPAA	
  compliance.	
  	
  
	
  
How	
  can	
  healthcare	
  professionals	
  be	
  proactive	
  in	
  keeping	
  PHI	
  safe	
  when	
  working	
  with	
  business	
  
associates?	
  	
  
	
  
Despite	
  the	
  best	
  of	
  intentions,	
  PHI	
  breaches	
  most	
  often	
  occur	
  due	
  to	
  lack	
  of	
  awareness	
  about	
  
HIPAA	
  guidelines	
  or	
  failure	
  to	
  follow	
  policies	
  that	
  are	
  in	
  place	
  to	
  prevent	
  breeches.	
  Particularly	
  in	
  
the	
  case	
  of	
  business	
  associates	
  who	
  do	
  not	
  typically	
  work	
  with	
  PHI,	
  personnel	
  may	
  lack	
  proper	
  
training	
  and	
  resources	
  to	
  protect	
  the	
  information.	
  Even	
  if	
  policies	
  are	
  in	
  place,	
  there	
  must	
  be	
  
accountability	
  to	
  ensure	
  the	
  policies	
  are	
  being	
  followed.	
  	
  
	
  
At	
  Gelb,	
  we	
  work	
  with	
  PHI	
  on	
  a	
  regular	
  basis	
  in	
  situations	
  such	
  as	
  in-­‐depth	
  interviewing	
  of	
  patients,	
  
conducting	
  focus	
  groups,	
  conducting	
  online	
  patient	
  surveys,	
  and	
  managing	
  CRM	
  dashboards.	
  Based	
  
on	
  our	
  experiences,	
  we	
  would	
  like	
  to	
  share	
  some	
  best	
  practices	
  for	
  healthcare	
  professionals	
  to	
  
consider	
  when	
  sharing	
  PHI	
  with	
  business	
  associates.	
  	
  	
  
The	
  Basics	
  of	
  Protecting	
  PHI	
  
	
  
©	
  2015	
  Gelb	
  Consulting.	
  All	
  Rights	
  Reserved.	
   	
   	
  
Page	
  3	
  
	
  
Confirming	
  Compliance:	
  Basic	
  Questions	
  to	
  Ask	
  	
  
Accountability	
  and	
  transparency	
  is	
  critical	
  in	
  protecting	
  PHI.	
  Even	
  if	
  a	
  BAA	
  is	
  in	
  place,	
  prior	
  to	
  
sharing	
  PHI	
  with	
  a	
  business	
  associate,	
  healthcare	
  professionals	
  should	
  initiate	
  discussion	
  and	
  ask	
  
questions	
  to	
  ensure	
  best	
  practices	
  and	
  regulations	
  are	
  being	
  followed.	
  	
  
	
  
1. Do	
  they	
  have	
  a	
  HIPAA	
  Privacy/Security	
  Officer,	
  and	
  does	
  that	
  person	
  understand	
  the	
  role	
  
he/she	
  plays	
  in	
  protecting	
  your	
  PHI?	
  
• Organizations	
  that	
  work	
  with	
  PHI	
  should	
  designate	
  and	
  maintain	
  a	
  HIPAA	
  
Privacy/Security	
  Officer.	
  	
  
• This	
  person	
  should	
  have	
  in-­‐depth	
  knowledge	
  of	
  HIPAA	
  regulations,	
  and	
  oversee	
  
compliance-­‐related	
  activities,	
  training	
  and	
  policies.	
  
	
  
2. Do	
  they	
  have	
  a	
  documented	
  HIPAA	
  
compliance	
  policy?	
  
• All	
  internal	
  compliance	
  related	
  
policies,	
  authorizations,	
  training	
  and	
  
other	
  related	
  documents	
  should	
  be	
  
clearly	
  documented	
  and	
  updated.	
  	
  	
  
• The	
  policy	
  should	
  explain	
  what	
  PHI	
  is	
  
and	
  how	
  it	
  will	
  be	
  handled	
  to	
  ensure	
  
compliance	
  with	
  the	
  regulations.	
  
• The	
  policy	
  should	
  be	
  available	
  to	
  all	
  
employees	
  and	
  those	
  who	
  will	
  be	
  exposed	
  to	
  PHI	
  must	
  confirm	
  that	
  they	
  have	
  read	
  
it	
  and	
  will	
  comply	
  with	
  it.	
  	
  	
  
• A	
  copy	
  of	
  their	
  policies	
  should	
  be	
  provided	
  to	
  you	
  if	
  you	
  request	
  it.	
  	
  
	
  
3. Who	
  will	
  have	
  access	
  to	
  PHI,	
  and	
  are	
  they	
  HIPAA	
  trained?	
  
• Any	
  personnel	
  who	
  have	
  access	
  to	
  PHI	
  should	
  complete	
  HIPAA	
  compliance	
  training.	
  
At	
  Gelb,	
  employees	
  must	
  go	
  through	
  several	
  training	
  courses	
  and	
  pass	
  a	
  written	
  
exam	
  prior	
  to	
  working	
  with	
  PHI.	
  	
  
• As	
  a	
  basic	
  starting	
  point,	
  employees	
  should	
  understand	
  what	
  is	
  considered	
  to	
  be	
  PHI,	
  
and	
  the	
  importance	
  of	
  protecting	
  the	
  information.	
  For	
  example,	
  it	
  is	
  a	
  common	
  
misconception	
  that	
  it	
  is	
  not	
  PHI	
  if	
  the	
  patient’s	
  specific	
  diagnosis	
  is	
  deleted.	
  	
  	
  
	
  
4. How	
  will	
  PHI	
  be	
  stored?	
  
• Most	
  documents	
  saved	
  on	
  a	
  company’s	
  shared	
  drive	
  or	
  a	
  cloud-­‐based	
  portal	
  are	
  
accessible	
  to	
  the	
  entire	
  company.	
  However,	
  PHI	
  should	
  only	
  be	
  accessible	
  on	
  a	
  
The	
  Basics	
  of	
  Protecting	
  PHI	
  
	
  
©	
  2015	
  Gelb	
  Consulting.	
  All	
  Rights	
  Reserved.	
   	
   	
  
Page	
  4	
  
	
  
“need	
  to	
  know”	
  basis.	
  At	
  Gelb,	
  we	
  have	
  separate	
  a	
  web	
  portal	
  for	
  each	
  project	
  that	
  
involves	
  PHI,	
  and	
  each	
  portal	
  is	
  only	
  accessible	
  to	
  those	
  who	
  truly	
  need	
  access.	
  	
  
• PHI	
  should	
  not	
  be	
  downloaded	
  or	
  saved	
  to	
  an	
  individual	
  computer	
  or	
  portable	
  
device,	
  but	
  instead	
  edited	
  or	
  accessed	
  through	
  the	
  portal.	
  In	
  a	
  rare	
  situation	
  in	
  
which	
  PHI	
  is	
  downloaded	
  (such	
  as	
  due	
  to	
  lack	
  of	
  internet	
  access	
  during	
  the	
  research),	
  
the	
  device	
  should	
  be	
  encrypted,	
  and	
  the	
  downloaded	
  PHI	
  should	
  be	
  deleted	
  as	
  soon	
  
as	
  possible.	
  PHI	
  saved	
  to	
  portable	
  devices	
  is	
  the	
  cause	
  of	
  many	
  news	
  stories	
  in	
  which	
  
privacy	
  is	
  breached	
  due	
  to	
  a	
  loss	
  or	
  theft.	
  	
  
• When	
  working	
  with	
  business	
  associates,	
  it	
  is	
  best	
  to	
  avoid	
  sharing	
  hard	
  copies	
  of	
  PHI.	
  
However	
  if	
  hard	
  copies	
  must	
  exist,	
  they	
  must	
  be	
  stored	
  under	
  lock	
  and	
  key	
  with	
  
documented	
  control	
  of	
  who	
  has	
  access.	
  	
  	
  	
  
	
  
5. How	
  will	
  PHI	
  be	
  shared	
  between	
  the	
  project	
  team	
  members?	
  
• Team	
  members	
  should	
  not	
  use	
  email	
  to	
  share	
  PHI	
  
documentation.	
  They	
  should	
  share	
  documents	
  via	
  a	
  
secure	
  server	
  or	
  online	
  portal.	
  	
  Although	
  hospitals	
  
might	
  have	
  specific	
  security	
  measures	
  in	
  place	
  that	
  
allow	
  them	
  to	
  email	
  PHI,	
  most	
  business	
  associates	
  do	
  
not	
  have	
  this	
  capability.	
  	
  
• The	
  business	
  associate	
  team	
  should	
  maintain	
  a	
  log	
  of	
  
PHI	
  sensitive	
  information	
  –	
  who	
  it	
  was	
  received	
  from,	
  
who	
  it	
  is	
  accessible	
  to,	
  any	
  situations	
  in	
  which	
  it	
  is	
  
transferred	
  or	
  shared,	
  and	
  when	
  it	
  was	
  destroyed.	
  	
  
	
  
• Tip:	
  The	
  number	
  of	
  documents	
  that	
  contain	
  PHI	
  
should	
  be	
  limited.	
  For	
  example,	
  if	
  the	
  team	
  is	
  working	
  
on	
  a	
  schedule	
  for	
  interviews	
  or	
  focus	
  groups,	
  PHI	
  can	
  
be	
  protected	
  by	
  assigning	
  each	
  patient	
  a	
  code.	
  The	
  
code	
  is	
  included	
  on	
  the	
  scheduling	
  documents	
  and	
  research	
  notes	
  rather	
  than	
  the	
  
patient’s	
  name.	
  This	
  allows	
  the	
  documents	
  to	
  be	
  emailed	
  and	
  shared	
  with	
  the	
  team	
  
without	
  compromising	
  privacy.	
  	
  
	
  
6. How	
  is	
  privacy	
  maintained	
  when	
  recruiting	
  or	
  speaking	
  with	
  patients?	
  
• In	
  marketing	
  research,	
  it	
  is	
  common	
  that	
  patients	
  need	
  to	
  be	
  recruited	
  for	
  interviews	
  
or	
  focus	
  groups.	
  It	
  is	
  important	
  that	
  those	
  contacting	
  the	
  patients	
  can	
  clearly	
  
communicate	
  how	
  they	
  obtained	
  their	
  name	
  and	
  information	
  to	
  dispel	
  concerns	
  that	
  
patients	
  might	
  have	
  about	
  their	
  privacy.	
  	
  
• Team	
  members	
  should	
  also	
  be	
  aware	
  of	
  how	
  much	
  information	
  they	
  share	
  via	
  a	
  
voicemail	
  or	
  message	
  left	
  with	
  another	
  person	
  who	
  answers	
  the	
  phone.	
  For	
  
example,	
  at	
  Gelb	
  we	
  leave	
  ambiguous	
  messages	
  or	
  voicemails	
  along	
  the	
  lines	
  of	
  “We	
  
The	
  Basics	
  of	
  Protecting	
  PHI	
  
	
  
©	
  2015	
  Gelb	
  Consulting.	
  All	
  Rights	
  Reserved.	
   	
   	
  
Page	
  5	
  
	
  
are	
  conducting	
  a	
  project	
  with	
  [name	
  of	
  hospital]	
  that	
  you	
  might	
  be	
  interested	
  in	
  
participating	
  in.”	
  Rather	
  than	
  explaining	
  that	
  we	
  are	
  calling	
  to	
  ask	
  about	
  their	
  
experience	
  with	
  the	
  Lung	
  Cancer	
  Program.	
  	
  
• Tip:	
  For	
  consistent	
  messaging,	
  it	
  is	
  helpful	
  to	
  have	
  a	
  client-­‐approved	
  recruiting	
  and	
  
voicemail	
  script.	
  It	
  is	
  also	
  helpful	
  for	
  the	
  research	
  team	
  to	
  avoid	
  using	
  full	
  names	
  on	
  
any	
  of	
  the	
  research	
  materials	
  (such	
  as	
  within	
  an	
  interview	
  transcript	
  or	
  within	
  the	
  
file	
  name)	
  and	
  instead	
  use	
  the	
  patient’s	
  code	
  so	
  that	
  the	
  transcript	
  does	
  not	
  become	
  
PHI.	
  	
  
	
  
7. Will	
  the	
  business	
  associate	
  be	
  utilizing	
  additional	
  subcontractors	
  or	
  service	
  providers?	
  If	
  so,	
  
are	
  they	
  HIPAA	
  compliant?	
  
• Business	
  associates	
  may	
  need	
  to	
  use	
  subcontractors	
  or	
  service	
  providers	
  for	
  
purposes	
  that	
  require	
  them	
  to	
  share	
  PHI	
  –	
  such	
  as	
  recruiting	
  for	
  research	
  or	
  
distributing	
  online	
  surveys.	
  In	
  these	
  situations,	
  the	
  business	
  associate	
  must	
  execute	
  
a	
  BAA	
  with	
  the	
  other	
  entity	
  to	
  ensure	
  that	
  it	
  is	
  HIPAA	
  compliant	
  as	
  well.	
  	
  
• At	
  Gelb,	
  all	
  subcontractors	
  and	
  service	
  provider	
  must	
  complete	
  training	
  and	
  enter	
  
into	
  a	
  BAA	
  that	
  outlines	
  safeguards	
  for	
  protecting	
  PHI.	
  Gelb	
  project	
  managers	
  
reinforce	
  these	
  guidelines	
  during	
  the	
  project.	
  
	
  
8. What	
  happens	
  to	
  PHI	
  after	
  the	
  project	
  is	
  completed?	
   	
  
• All	
  PHI	
  should	
  be	
  shredded	
  at	
  the	
  completion	
  of	
  a	
  project.	
  	
  	
  
	
  
Tip:	
  At	
  the	
  end	
  of	
  a	
  project,	
  ask	
  the	
  business	
  associate	
  team	
  to	
  conduct	
  a	
  “PHI	
  
Check”	
  to	
  ensure	
  all	
  PHI	
  documentation	
  related	
  to	
  the	
  project	
  has	
  been	
  destroyed.	
  
This	
  includes	
  checking	
  servers,	
  online	
  portals,	
  portable	
  devices	
  and	
  hard	
  copies.	
  	
  	
  
	
  
Key	
  Takeaway	
  –	
  Transparency	
  and	
  Accountability	
  are	
  Critical	
  
Sharing	
  PHI	
  with	
  business	
  associates	
  is	
  often	
  necessary,	
  and	
  can	
  result	
  in	
  valuable	
  information	
  and	
  
technology.	
  However,	
  a	
  lack	
  of	
  explicit	
  discussion	
  between	
  healthcare	
  professionals	
  and	
  business	
  
associates	
  about	
  how	
  PHI	
  will	
  be	
  handled	
  makes	
  a	
  breech	
  more	
  likely.	
  Prior	
  to	
  sharing	
  PHI,	
  
healthcare	
  personnel	
  should	
  initiate	
  conversation	
  and	
  ask	
  detailed	
  questions	
  about	
  the	
  business	
  
associate’s	
  HIPAA-­‐related	
  policies	
  to	
  ensure	
  that	
  best	
  practices	
  and	
  regulations	
  are	
  being	
  followed.	
  
Ultimately,	
  transparency	
  and	
  accountability	
  are	
  critical	
  for	
  both	
  organizations	
  in	
  not	
  only	
  following	
  
the	
  law,	
  but	
  also	
  in	
  maintaining	
  patient	
  trust	
  and	
  confidence.	
  	
  
	
  
	
  
	
  
The	
  Basics	
  of	
  Protecting	
  PHI	
  
	
  
©	
  2015	
  Gelb	
  Consulting.	
  All	
  Rights	
  Reserved.	
   	
   	
  
Page	
  6	
  
	
  
About	
  Endeavor	
  	
  
Endeavor	
  Management,	
  is	
  an	
  international	
  management	
  consulting	
  firm	
  that	
  collaboratively	
  works	
  
with	
  their	
  clients	
  to	
  achieve	
  greater	
  value	
  from	
  their	
  transformational	
  business	
  initiatives.	
  Endeavor	
  
serves	
   as	
   a	
   catalyst	
   by	
   providing	
   pragmatic	
   methodologies	
   and	
   industry	
   expertise	
   in	
  
Transformational	
   Strategies,	
   Operational	
   Excellence,	
   Organizational	
   Effectiveness,	
   and	
  
Transformational	
  Leadership.	
  
Our	
  clients	
  include	
  those	
  responsible	
  for:	
  
• Business	
  Strategy	
  
• Marketing	
  and	
  Brand	
  Strategy	
  
• Operations	
  
• Technology	
  Deployment	
  
• Strategic	
  Human	
  Capital	
  
• Corporate	
  Finance	
  
	
  
The	
  firm’s	
  50	
  year	
  heritage	
  has	
  produced	
  a	
  substantial	
  portfolio	
  of	
  proven	
  methodologies,	
  deep	
  
operational	
  insight	
  and	
  broad	
  industry	
  experience.	
  	
  This	
  experience	
  enables	
  our	
  team	
  to	
  quickly	
  
understand	
  the	
  dynamics	
  of	
  client	
  companies	
  and	
  markets.	
  	
  Endeavor’s	
  clients	
  span	
  the	
  globe	
  and	
  
are	
  typically	
  leaders	
  in	
  their	
  industry.	
  	
  
Gelb	
   Consulting	
   Group,	
   a	
   wholly	
   owned	
   subsidiary,	
   monitors	
   organizational	
   performance	
   and	
  
designs	
  winning	
  marketing	
  strategies.	
  	
  Gelb	
  helps	
  organizations	
  focus	
  their	
  marketing	
  initiatives	
  by	
  
fully	
   understanding	
   customer	
   needs	
   through	
   proven	
   strategic	
   frameworks	
   to	
   guide	
   marketing	
  
strategies,	
  build	
  trusted	
  brands,	
  deliver	
  exceptional	
  experiences	
  and	
  launch	
  new	
  products.	
  	
  Gelb	
  
can	
  help	
  you	
  to	
  develop	
  and	
  implement	
  the	
  right	
  strategies.	
  	
  Using	
  advanced	
  research	
  techniques,	
  
Gelb	
   can	
   help	
   you	
   to	
   understand	
   the	
   complexities	
   of	
   your	
   market,	
   to	
   develop	
   your	
   strategic	
  
decision	
  frameworks	
  and	
  to	
  determine	
  the	
  best	
  deployment	
  of	
  your	
  resources	
  and	
  technology	
  to	
  
monitor	
  your	
  successes.	
  	
  
For	
  over	
  50	
  years,	
  Gelb	
  has	
  worked	
  with	
  marketing	
  leaders	
  on:	
  
• 	
  	
  	
  Strategic	
  Marketing	
  
• 	
  	
  	
  Brand	
  Building	
  
• 	
  	
  	
  Customer	
  Experience	
  Management	
  
• 	
  	
  	
  Go	
  to	
  Market	
  
• 	
  	
  	
  Product	
  Innovation	
  
• 	
  	
  	
  Trademark/Trade	
  Dress	
  Protection	
  
	
  
	
  
Our	
  websites:	
  
www.endeavormgmt.com	
  
www.gelbconsulting.com	
  
www.gulfresearch.com	
  

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The Basics of Protecting PHI - Best Practices When Working with Business Associates

  • 1. The  Basics  of  Protecting  PHI   Best Practices when Working with Business Associates Gelb, An Endeavor Management Company 1011 Highway 6 South P + 281.759.3600 Suite 120 F + 281.759.3607 Houston, Texas 77077 www.gelbconsulting.com  
  • 2. The  Basics  of  Protecting  PHI     ©  2015  Gelb  Consulting.  All  Rights  Reserved.       Page  2     Note:  We  are  not  attorneys  and  this  represents  our  experience  in  working  with   healthcare  organizations.    This  should  not  be  considered  legal  advice.         Overview   The  Health  Insurance  Portability  and  Accountability  Act  (HIPAA)  placed  clear  responsibility  on   healthcare  providers  to  protect  individually  identifiable  health  information.  Hospitals  and   healthcare  professionals  who  work  with  this  type  of  information  everyday  are  familiar  with  HIPAA   requirements.  However,  when  external  business  associates  are  engaged  for  activities  in  which   protected  health  information  (PHI)  is  accessible  or  shared,  there  is  often  a  lack  of  explicit  discussion   about  how  to  protect  PHI.       HIPPA  rules  stipulate  that  business  associates  are  directly  liable  for  following  HIPAA  requirements   when  working  with  PHI.  For  this  reason,  healthcare  providers  are  required  to  employ  a  business   associate  agreement  (BAA)  or  other  written  arrangement  that  specifies  how  the  business  associate   will  comply  with  HIPAA.  Nevertheless,  business  associates  may  be  unaware  of  the  full  breadth  of   regulations  or  lack  the  experience  and/or  resources  to  put  proper  safeguards  in  place.  In  fact,   according  to  the  U.S.  Department  of  Health  &  Human  Services,  some  of  the  largest  HIPAA  breaches   have  involved  business  associates.  From  Gelb’s  perspective  as  a  small  business  that  works  with  PHI,   HIPAA  has  complex  guidelines  that  require  time  and  resources  to  fully  understand  and  ensure   compliance.     Privacy  violations  –  whether  the  fault  of  a  hospital  representative  or  a  business  associate  –  can  be  a   public  relations  nightmare  and  violate  the  trust  of  the  community.  For  this  reason,  it  is  important   for  hospitals  to  go  beyond  a  BAA  when  considering  HIPAA  compliance.       How  can  healthcare  professionals  be  proactive  in  keeping  PHI  safe  when  working  with  business   associates?       Despite  the  best  of  intentions,  PHI  breaches  most  often  occur  due  to  lack  of  awareness  about   HIPAA  guidelines  or  failure  to  follow  policies  that  are  in  place  to  prevent  breeches.  Particularly  in   the  case  of  business  associates  who  do  not  typically  work  with  PHI,  personnel  may  lack  proper   training  and  resources  to  protect  the  information.  Even  if  policies  are  in  place,  there  must  be   accountability  to  ensure  the  policies  are  being  followed.       At  Gelb,  we  work  with  PHI  on  a  regular  basis  in  situations  such  as  in-­‐depth  interviewing  of  patients,   conducting  focus  groups,  conducting  online  patient  surveys,  and  managing  CRM  dashboards.  Based   on  our  experiences,  we  would  like  to  share  some  best  practices  for  healthcare  professionals  to   consider  when  sharing  PHI  with  business  associates.      
  • 3. The  Basics  of  Protecting  PHI     ©  2015  Gelb  Consulting.  All  Rights  Reserved.       Page  3     Confirming  Compliance:  Basic  Questions  to  Ask     Accountability  and  transparency  is  critical  in  protecting  PHI.  Even  if  a  BAA  is  in  place,  prior  to   sharing  PHI  with  a  business  associate,  healthcare  professionals  should  initiate  discussion  and  ask   questions  to  ensure  best  practices  and  regulations  are  being  followed.       1. Do  they  have  a  HIPAA  Privacy/Security  Officer,  and  does  that  person  understand  the  role   he/she  plays  in  protecting  your  PHI?   • Organizations  that  work  with  PHI  should  designate  and  maintain  a  HIPAA   Privacy/Security  Officer.     • This  person  should  have  in-­‐depth  knowledge  of  HIPAA  regulations,  and  oversee   compliance-­‐related  activities,  training  and  policies.     2. Do  they  have  a  documented  HIPAA   compliance  policy?   • All  internal  compliance  related   policies,  authorizations,  training  and   other  related  documents  should  be   clearly  documented  and  updated.       • The  policy  should  explain  what  PHI  is   and  how  it  will  be  handled  to  ensure   compliance  with  the  regulations.   • The  policy  should  be  available  to  all   employees  and  those  who  will  be  exposed  to  PHI  must  confirm  that  they  have  read   it  and  will  comply  with  it.       • A  copy  of  their  policies  should  be  provided  to  you  if  you  request  it.       3. Who  will  have  access  to  PHI,  and  are  they  HIPAA  trained?   • Any  personnel  who  have  access  to  PHI  should  complete  HIPAA  compliance  training.   At  Gelb,  employees  must  go  through  several  training  courses  and  pass  a  written   exam  prior  to  working  with  PHI.     • As  a  basic  starting  point,  employees  should  understand  what  is  considered  to  be  PHI,   and  the  importance  of  protecting  the  information.  For  example,  it  is  a  common   misconception  that  it  is  not  PHI  if  the  patient’s  specific  diagnosis  is  deleted.         4. How  will  PHI  be  stored?   • Most  documents  saved  on  a  company’s  shared  drive  or  a  cloud-­‐based  portal  are   accessible  to  the  entire  company.  However,  PHI  should  only  be  accessible  on  a  
  • 4. The  Basics  of  Protecting  PHI     ©  2015  Gelb  Consulting.  All  Rights  Reserved.       Page  4     “need  to  know”  basis.  At  Gelb,  we  have  separate  a  web  portal  for  each  project  that   involves  PHI,  and  each  portal  is  only  accessible  to  those  who  truly  need  access.     • PHI  should  not  be  downloaded  or  saved  to  an  individual  computer  or  portable   device,  but  instead  edited  or  accessed  through  the  portal.  In  a  rare  situation  in   which  PHI  is  downloaded  (such  as  due  to  lack  of  internet  access  during  the  research),   the  device  should  be  encrypted,  and  the  downloaded  PHI  should  be  deleted  as  soon   as  possible.  PHI  saved  to  portable  devices  is  the  cause  of  many  news  stories  in  which   privacy  is  breached  due  to  a  loss  or  theft.     • When  working  with  business  associates,  it  is  best  to  avoid  sharing  hard  copies  of  PHI.   However  if  hard  copies  must  exist,  they  must  be  stored  under  lock  and  key  with   documented  control  of  who  has  access.           5. How  will  PHI  be  shared  between  the  project  team  members?   • Team  members  should  not  use  email  to  share  PHI   documentation.  They  should  share  documents  via  a   secure  server  or  online  portal.    Although  hospitals   might  have  specific  security  measures  in  place  that   allow  them  to  email  PHI,  most  business  associates  do   not  have  this  capability.     • The  business  associate  team  should  maintain  a  log  of   PHI  sensitive  information  –  who  it  was  received  from,   who  it  is  accessible  to,  any  situations  in  which  it  is   transferred  or  shared,  and  when  it  was  destroyed.       • Tip:  The  number  of  documents  that  contain  PHI   should  be  limited.  For  example,  if  the  team  is  working   on  a  schedule  for  interviews  or  focus  groups,  PHI  can   be  protected  by  assigning  each  patient  a  code.  The   code  is  included  on  the  scheduling  documents  and  research  notes  rather  than  the   patient’s  name.  This  allows  the  documents  to  be  emailed  and  shared  with  the  team   without  compromising  privacy.       6. How  is  privacy  maintained  when  recruiting  or  speaking  with  patients?   • In  marketing  research,  it  is  common  that  patients  need  to  be  recruited  for  interviews   or  focus  groups.  It  is  important  that  those  contacting  the  patients  can  clearly   communicate  how  they  obtained  their  name  and  information  to  dispel  concerns  that   patients  might  have  about  their  privacy.     • Team  members  should  also  be  aware  of  how  much  information  they  share  via  a   voicemail  or  message  left  with  another  person  who  answers  the  phone.  For   example,  at  Gelb  we  leave  ambiguous  messages  or  voicemails  along  the  lines  of  “We  
  • 5. The  Basics  of  Protecting  PHI     ©  2015  Gelb  Consulting.  All  Rights  Reserved.       Page  5     are  conducting  a  project  with  [name  of  hospital]  that  you  might  be  interested  in   participating  in.”  Rather  than  explaining  that  we  are  calling  to  ask  about  their   experience  with  the  Lung  Cancer  Program.     • Tip:  For  consistent  messaging,  it  is  helpful  to  have  a  client-­‐approved  recruiting  and   voicemail  script.  It  is  also  helpful  for  the  research  team  to  avoid  using  full  names  on   any  of  the  research  materials  (such  as  within  an  interview  transcript  or  within  the   file  name)  and  instead  use  the  patient’s  code  so  that  the  transcript  does  not  become   PHI.       7. Will  the  business  associate  be  utilizing  additional  subcontractors  or  service  providers?  If  so,   are  they  HIPAA  compliant?   • Business  associates  may  need  to  use  subcontractors  or  service  providers  for   purposes  that  require  them  to  share  PHI  –  such  as  recruiting  for  research  or   distributing  online  surveys.  In  these  situations,  the  business  associate  must  execute   a  BAA  with  the  other  entity  to  ensure  that  it  is  HIPAA  compliant  as  well.     • At  Gelb,  all  subcontractors  and  service  provider  must  complete  training  and  enter   into  a  BAA  that  outlines  safeguards  for  protecting  PHI.  Gelb  project  managers   reinforce  these  guidelines  during  the  project.     8. What  happens  to  PHI  after  the  project  is  completed?     • All  PHI  should  be  shredded  at  the  completion  of  a  project.         Tip:  At  the  end  of  a  project,  ask  the  business  associate  team  to  conduct  a  “PHI   Check”  to  ensure  all  PHI  documentation  related  to  the  project  has  been  destroyed.   This  includes  checking  servers,  online  portals,  portable  devices  and  hard  copies.         Key  Takeaway  –  Transparency  and  Accountability  are  Critical   Sharing  PHI  with  business  associates  is  often  necessary,  and  can  result  in  valuable  information  and   technology.  However,  a  lack  of  explicit  discussion  between  healthcare  professionals  and  business   associates  about  how  PHI  will  be  handled  makes  a  breech  more  likely.  Prior  to  sharing  PHI,   healthcare  personnel  should  initiate  conversation  and  ask  detailed  questions  about  the  business   associate’s  HIPAA-­‐related  policies  to  ensure  that  best  practices  and  regulations  are  being  followed.   Ultimately,  transparency  and  accountability  are  critical  for  both  organizations  in  not  only  following   the  law,  but  also  in  maintaining  patient  trust  and  confidence.          
  • 6. The  Basics  of  Protecting  PHI     ©  2015  Gelb  Consulting.  All  Rights  Reserved.       Page  6     About  Endeavor     Endeavor  Management,  is  an  international  management  consulting  firm  that  collaboratively  works   with  their  clients  to  achieve  greater  value  from  their  transformational  business  initiatives.  Endeavor   serves   as   a   catalyst   by   providing   pragmatic   methodologies   and   industry   expertise   in   Transformational   Strategies,   Operational   Excellence,   Organizational   Effectiveness,   and   Transformational  Leadership.   Our  clients  include  those  responsible  for:   • Business  Strategy   • Marketing  and  Brand  Strategy   • Operations   • Technology  Deployment   • Strategic  Human  Capital   • Corporate  Finance     The  firm’s  50  year  heritage  has  produced  a  substantial  portfolio  of  proven  methodologies,  deep   operational  insight  and  broad  industry  experience.    This  experience  enables  our  team  to  quickly   understand  the  dynamics  of  client  companies  and  markets.    Endeavor’s  clients  span  the  globe  and   are  typically  leaders  in  their  industry.     Gelb   Consulting   Group,   a   wholly   owned   subsidiary,   monitors   organizational   performance   and   designs  winning  marketing  strategies.    Gelb  helps  organizations  focus  their  marketing  initiatives  by   fully   understanding   customer   needs   through   proven   strategic   frameworks   to   guide   marketing   strategies,  build  trusted  brands,  deliver  exceptional  experiences  and  launch  new  products.    Gelb   can  help  you  to  develop  and  implement  the  right  strategies.    Using  advanced  research  techniques,   Gelb   can   help   you   to   understand   the   complexities   of   your   market,   to   develop   your   strategic   decision  frameworks  and  to  determine  the  best  deployment  of  your  resources  and  technology  to   monitor  your  successes.     For  over  50  years,  Gelb  has  worked  with  marketing  leaders  on:   •      Strategic  Marketing   •      Brand  Building   •      Customer  Experience  Management   •      Go  to  Market   •      Product  Innovation   •      Trademark/Trade  Dress  Protection       Our  websites:   www.endeavormgmt.com   www.gelbconsulting.com   www.gulfresearch.com