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Big Data,
HIPAA
And
The Common
Rule:
Time for Big
Change?
Margaret	
  Foster	
  Riley,	
  J.D.
Big	
  Data,	
  Health	
  Law	
  
and	
  Bioethics
Harvard	
  Law	
  School
May	
  6,	
  2016
THE COMMON RULE AND IRBS
TWENTIETH CENTURY MODEL
§ Academic Centers
§ Phenotypic Disease Model
§ Traditional Clinical Trial Design
§ Time, place, and inclusion
§ Clearer Lines between Clinical
Treatment and Research
§ Paper Record
HIPAA: TOO EARLY, OUT OF
DATE AND WAY TOO
COMPLICATED?
§ Pre-Genomic/Molecular/NetworkIdentifiers
§ TrueDe-Identification,even when HIPAA
identifiers areremoved,is very difficult
§ But there are (sophisticated)analytics thatcan be
used
§ Mostof theseare beyond the capabilities of most
IRBs (if acting as Privacy Board) and many
institutions
§ The morecomplex (useful!)the data,the more
difficultthis may be
§ We want sharingbetweeninstitutions
NETWORKED MEDICINE
A	
  tremendous	
  amount	
  of	
  this	
  data	
  comes	
  from	
  sources	
  outside	
  the
typical	
  health	
  record
DATASOURCES IN
NETWORKED MEDICINE
Claims	
  and	
  Cost	
  Data;	
  
depending	
  on	
  the	
  entity	
  subject	
  
to/or	
  not	
  HIPAA	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  
Pharmaceutical/Laboratory	
  R&D;	
  
may	
  be	
  subject	
  to	
  HIPAA;	
  	
  but	
  
depends	
  on	
  how	
  data	
  is	
  acquired;	
  	
  
Trade	
  Secrets	
  may	
  apply
Clinical	
  Data	
  Controlled	
  by	
  Providers;	
  
generally	
  subject	
  to	
  HIPAA/Digital	
  
Ownership	
  Unclear
Patient	
  Behavior	
  and	
  Preferences;	
  
Depending	
  on	
  Source	
  may	
  be	
  
outside	
  HIPAA	
  and	
  Commercially	
  
Owned
Rapidly	
  
increasing	
  
Commercial	
  
Use
§ Adaptive clinical trials
§ “Large Simple Studies” and “Pragmatic
Trials”
§ Research networks
INCREASINGLY DIFFICULT TO
DISTINGUISH RESEARCH FROM
CLINICAL CARE
THE DARK SIDE OF HIT
§ With health IT, it is now possiblefor the first
time in the history of medicine to:
§ Violate the health privacy of millions of individuals in
a matter of seconds
§ Steal health information without having physical
access to it; and
§ Violate an individual’s health information privacy in a
manner that makes it impossible to restore. “The
Financial Impact of Breached PHI”, ANSI (March 2012)
http://webstore.ansi.org/phi
BUT DOES RESEARCHADD
RISKS?
§ Most breaches and compromise are
part of the clinical process
§ Many of those breaches are bread and
butter financial fraud
§ Research (sadly?) is a fairly minor
application of Big Data Health
Information use
COMMON RULE NEEDSA MAJOR
OVERHAULTO DEAL WITH DATA
ISSUES
§ Simply adding new rules does not do the
trick; complicates rather than simplifies
§ Fundamental Disagreement is on where
notice is sufficient vs. full informed
consent
§ —Notions of Autonomy
§ Faden/Kass consistent w/ general privacy law
(notice is sufficient)
§ Miller—health care is different
FUNDAMENTALCHARACTERISTICS OF
BIG DATA CHALLENGETHE
STRUCTURE OF THE COMMON RULE
AND HIPAA
§ The analysisof Big Data is oftenfor a different
purposethanthe purposefor which it was
originallycollected
§ How does one do meaningful consent?
§ The volumeof data used forBig Data purposes
means that it comes from many sources
§ Outside the purview of any single (or many) IRBs
A PATCHWORK SYSTEM OF PRIVACY
LAW IN THE UNITED STATES
§ The United States does not have comprehensive
federal privacy laws
§ Privacy Law in the United States is Sectoral (but
Federal TradeCommission/OCRplay overarching
regulatoryroles)
§ Health
§ Finance
§ Education
§ States also haveprivacy laws—which mayor may
not be pre-empted
PRIVACY, CONTROLAND
OWNERSHIP
§ Context driven privacy interests
§ Unclear rules on ownership
§ But rarely the individual that the data
describes
§ Illusory Control
CENTRALPRINCIPLES FOR PRIVACY
COMPLIANCE RELATING TO (ANY)
DATA COLLECTION: TRANSPARENCY
AND PROTECTION
§ Transparency
§ Notice -how will the data be used and shared
§ Choice- the individual’s desires as to that
use and sharing
§ Access-howthe individual can implement
those desires—thismeans a meaningful“opt
out”
§ Security Protections
BIG DATA REALLY
REQUIRESA
COMPREHENSIVE (NON-
SECTORAL)APPROACH
§ This requires us to fully examine the
question: is health care really different?
§ If not, perhaps then we should have an
data/informationalrisk scheme for
research that is driven by all needs
rather than tacking on HIPAA notions to
other areas

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Margaret Foster Riley, "Big Data, HIPAA, and the Common Rule: Time for Big Change?"

  • 1. Big Data, HIPAA And The Common Rule: Time for Big Change? Margaret  Foster  Riley,  J.D. Big  Data,  Health  Law   and  Bioethics Harvard  Law  School May  6,  2016
  • 2. THE COMMON RULE AND IRBS TWENTIETH CENTURY MODEL § Academic Centers § Phenotypic Disease Model § Traditional Clinical Trial Design § Time, place, and inclusion § Clearer Lines between Clinical Treatment and Research § Paper Record
  • 3. HIPAA: TOO EARLY, OUT OF DATE AND WAY TOO COMPLICATED? § Pre-Genomic/Molecular/NetworkIdentifiers § TrueDe-Identification,even when HIPAA identifiers areremoved,is very difficult § But there are (sophisticated)analytics thatcan be used § Mostof theseare beyond the capabilities of most IRBs (if acting as Privacy Board) and many institutions § The morecomplex (useful!)the data,the more difficultthis may be § We want sharingbetweeninstitutions
  • 4. NETWORKED MEDICINE A  tremendous  amount  of  this  data  comes  from  sources  outside  the typical  health  record
  • 5. DATASOURCES IN NETWORKED MEDICINE Claims  and  Cost  Data;   depending  on  the  entity  subject   to/or  not  HIPAA                                                                                                                                                                                                                             Pharmaceutical/Laboratory  R&D;   may  be  subject  to  HIPAA;    but   depends  on  how  data  is  acquired;     Trade  Secrets  may  apply Clinical  Data  Controlled  by  Providers;   generally  subject  to  HIPAA/Digital   Ownership  Unclear Patient  Behavior  and  Preferences;   Depending  on  Source  may  be   outside  HIPAA  and  Commercially   Owned Rapidly   increasing   Commercial   Use
  • 6. § Adaptive clinical trials § “Large Simple Studies” and “Pragmatic Trials” § Research networks INCREASINGLY DIFFICULT TO DISTINGUISH RESEARCH FROM CLINICAL CARE
  • 7. THE DARK SIDE OF HIT § With health IT, it is now possiblefor the first time in the history of medicine to: § Violate the health privacy of millions of individuals in a matter of seconds § Steal health information without having physical access to it; and § Violate an individual’s health information privacy in a manner that makes it impossible to restore. “The Financial Impact of Breached PHI”, ANSI (March 2012) http://webstore.ansi.org/phi
  • 8. BUT DOES RESEARCHADD RISKS? § Most breaches and compromise are part of the clinical process § Many of those breaches are bread and butter financial fraud § Research (sadly?) is a fairly minor application of Big Data Health Information use
  • 9. COMMON RULE NEEDSA MAJOR OVERHAULTO DEAL WITH DATA ISSUES § Simply adding new rules does not do the trick; complicates rather than simplifies § Fundamental Disagreement is on where notice is sufficient vs. full informed consent § —Notions of Autonomy § Faden/Kass consistent w/ general privacy law (notice is sufficient) § Miller—health care is different
  • 10. FUNDAMENTALCHARACTERISTICS OF BIG DATA CHALLENGETHE STRUCTURE OF THE COMMON RULE AND HIPAA § The analysisof Big Data is oftenfor a different purposethanthe purposefor which it was originallycollected § How does one do meaningful consent? § The volumeof data used forBig Data purposes means that it comes from many sources § Outside the purview of any single (or many) IRBs
  • 11. A PATCHWORK SYSTEM OF PRIVACY LAW IN THE UNITED STATES § The United States does not have comprehensive federal privacy laws § Privacy Law in the United States is Sectoral (but Federal TradeCommission/OCRplay overarching regulatoryroles) § Health § Finance § Education § States also haveprivacy laws—which mayor may not be pre-empted
  • 12. PRIVACY, CONTROLAND OWNERSHIP § Context driven privacy interests § Unclear rules on ownership § But rarely the individual that the data describes § Illusory Control
  • 13. CENTRALPRINCIPLES FOR PRIVACY COMPLIANCE RELATING TO (ANY) DATA COLLECTION: TRANSPARENCY AND PROTECTION § Transparency § Notice -how will the data be used and shared § Choice- the individual’s desires as to that use and sharing § Access-howthe individual can implement those desires—thismeans a meaningful“opt out” § Security Protections
  • 14. BIG DATA REALLY REQUIRESA COMPREHENSIVE (NON- SECTORAL)APPROACH § This requires us to fully examine the question: is health care really different? § If not, perhaps then we should have an data/informationalrisk scheme for research that is driven by all needs rather than tacking on HIPAA notions to other areas