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HDC Webinar Series
Addressing Privacy and Security Concerns to
Unlock Insights in Big Data in Healthcare
Deven McGraw, Man...
Addressing Privacy and Security Concerns
to Unlock Insights in Big Data in Healthcare
Deven McGraw, JD, MPH, LLM
Partner
M...
Health “Big Data”
 Data analytics conducted by “traditional health care system” is regulated
by HIPAA.
 Health data (and...
How does HIPAA govern analytic uses of data?
 HIPAA applies only to individually identifiable health information – data t...
HIPAA & Analytics (cont.)
 Before fully identifiable information can be used for research purposes, the
patient’s authori...
HIPAA & Analytics (3)
 Uses and disclosures of identifiable health data for “health care operations”
do not require indiv...
The Common Rule
 Applies to federally funded research (or research in federally funded
institutions) on identifiable data...
The Common Rule (cont.)
 ANPRM sought comment on fairly significant changes
 Research on data collected for clinical pur...
Issues with Current Federal Legal Frameworks Governing
Health Data Analytics
 Genuine confusion about application of the ...
Research vs. Operations
 HIPAA
 Health care operations includes “conducting quality assessment and improvement
activitie...
Paradox
 Two studies using data for quality improvement purposes: both use the
same data points, are done to address the ...
Health IT Policy Committee (HITECH) Comments to Common
Rule ANPRM
 Use of clinical data to evaluate safety, quality and e...
Criticisms of Current Legal Requirements
 Regulations should ideally be based on risk – risk with respect to the
interven...
Fair Information Practices – Markle Common
Framework
 Openness and transparency
 Purpose specification and
minimization
...
Potential Paths Forward
 Increased focus on discriminatory/harmful uses (but don’t ignore risks
inherent in collection)
...
White House Big Data Report
 Released May 2014
 Distinction between “big data” and “small data”: Big data is characteriz...
White House Big Data Recommendations*
 Current policy frameworks may work well enough for small data, but they
do not mee...
White House Big Data Recommendations
 Advance the Consumer Privacy Bill of Rights, including drafting of
legislative text...
PCAST Big Data Technology Report
 Policy attention should focus more on the actual uses of big data and less on its
colle...
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Addressing Privacy and Security Concerns to Unlock Insights in Big Data in Healthcare

Watch the webinar here: http://www.screencast.com/t/6E1ZgTOb

Deven McGraw, Partner at Manatt, Phelps & Phillips, discussed privacy and security concerns in regards to the liberation and usage of health data. There is enormous potential to glean valuable insights from large data sets of health (and health-related) information - but the collection and use of health information for analytics purposes raises privacy and security concerns. Solution of these issues is key to realizing the benefits of health big data. This presentation will focus primarily on some of the regulatory challenges to learning uses of clinical and administrative claims data but also touch on challenges to big data analytics in other contexts (for example, government data and data collected by consumer-facing commercial entities like mobile health apps, social networking sites, search engines, and other personal health tools).

Discover more health data resources on our website at http://www.healthdataconsortium.org/

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Addressing Privacy and Security Concerns to Unlock Insights in Big Data in Healthcare

  1. 1. HDC Webinar Series Addressing Privacy and Security Concerns to Unlock Insights in Big Data in Healthcare Deven McGraw, Manatt, Phelps & Phillips, LLP Introduced by Dwayne Spradlin, CEO Health Data Consortium
  2. 2. Addressing Privacy and Security Concerns to Unlock Insights in Big Data in Healthcare Deven McGraw, JD, MPH, LLM Partner Manatt, Phelps & Phillips, LLP
  3. 3. Health “Big Data”  Data analytics conducted by “traditional health care system” is regulated by HIPAA.  Health data (and data with health implications) collected, used and disclosed by consumer-facing and non-health care system entities is not.  FTC has authority to address unfair or deceptive practices engaged in by for-profit companies; also enforce HITECH data breach notification for personal health record vendors & related apps.  Aim should be to support and build public trust in data analytics that advance the learning health care system.
  4. 4. How does HIPAA govern analytic uses of data?  HIPAA applies only to individually identifiable health information – data that is “de-identified” per HIPAA standards is not subject to any regulation.  “Limited Data Sets” (the close cousin to de-identified data) are permitted for research; data holders are required to execute data use agreements; individual consent typically not required.  We are familiar with research networks that rely on these data types – but not always ideal for all types of research
  5. 5. HIPAA & Analytics (cont.)  Before fully identifiable information can be used for research purposes, the patient’s authorization must be obtained (currently authorization must be study specific – but Omnibus rule allows for authorizations for future research, as long as that future research is “sufficiently described”)  Can be waived by a Privacy Board or IRB if too difficult to obtain authorization, risk to privacy is considered to be low, and benefits are high  Some exceptions (review of data onsite in preparation for research, research on decedent’s info, and use of limited data set)  Scope of new rule uncertain
  6. 6. HIPAA & Analytics (3)  Uses and disclosures of identifiable health data for “health care operations” do not require individual consent or authorization  Includes conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines; population-based activities relating to improving health or reducing costs  However, if “obtaining of generalizable knowledge” is a primary purpose of these activities, it is considered “research” and not operations
  7. 7. The Common Rule  Applies to federally funded research (or research in federally funded institutions) on identifiable data  Includes health services research  Review of IRB (either full or expedited) required  Consent required, although can be waived if:  The research involves no more than minimal risk  The waiver will not adversely affect the rights & welfare of subjects  The research could not be practicably conducted w/out the waiver; and  When appropriate, subjects are provided with additional info after participation.
  8. 8. The Common Rule (cont.)  ANPRM sought comment on fairly significant changes  Research on data collected for clinical purposes but secondarily used for research purposes would be exempt from requiring IRB approval –one-two page registration of study with IRB/institution required instead  If data are identifiable, consent is required (but general consent would suffice);  Rely on HIPAA for standards of identifiability  Require adoption of data security protections  Biospecimens collected for clinical purposes – requires consent for research even if not identifiable  Unclear if/when proposed rule will be issued…
  9. 9. Issues with Current Federal Legal Frameworks Governing Health Data Analytics  Genuine confusion about application of the rules  Overly conservative interpretation of the rules – in most cases, HIPAA says “can” not “must”  Health services research often requires multiple sites to work together – typically not easy  Data as an asset  Data holders have a legal responsibility to protect; variances in risk tolerance  Differences in state law can also create obstacles
  10. 10. Research vs. Operations  HIPAA  Health care operations includes “conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities.” (emphasis added) Also includes “population-based activities relating to improving health or reducing health care costs, and protocol development.  Research is a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”  Common Rule has the same definition for research.
  11. 11. Paradox  Two studies using data for quality improvement purposes: both use the same data points, are done to address the same question or sets of questions, and are done by the same institution. They will be:  Treated as operations if the results are only intended to be used internally  Treated as research if a primary purpose is to share the results with others so that “learning” may occur.  Guidance on “primary purpose” allows for a later change in plans – but initially you have to intend to be doing only operations  How does this advance both the learning healthcare system and protections for data?
  12. 12. Health IT Policy Committee (HITECH) Comments to Common Rule ANPRM  Use of clinical data to evaluate safety, quality and efficacy should be treated like operations, even if the intent is to share results for generalizable knowledge, as long as provider entity maintains oversight and control over data use decisions.  Entities should follow the full complement of fair information practices in using PHI for these purposes.  Recommendations provided some examples of activities with clinical data that should be treated as operations – but also acknowledged further work was needed to determine a new line for when analytics with EHR data should be treated under more robust rules. Recommendation letter of 10/18/11 - http://www.healthit.gov/policy-researchers-implementers/health-it-policy- committee-recommendations-national-coordinator-heal
  13. 13. Criticisms of Current Legal Requirements  Regulations should ideally be based on risk – risk with respect to the intervention being studied and risk with respect to privacy & confidentiality.  De-identification is an important data protection tool but it is not infallible (still very low risk of re-identification; some types of “data” raise more risk).  Failure to address broad spectrum of fair information practices – more emphasis on consent, data identifiability.  No incentives in the law to pursue privacy-protective data sharing architectures.
  14. 14. Fair Information Practices – Markle Common Framework  Openness and transparency  Purpose specification and minimization  Collection limitation  Use limitation  Individual participation and control  Data integrity and quality  Security safeguards and controls  Accountability and Oversight  Remedies
  15. 15. Potential Paths Forward  Increased focus on discriminatory/harmful uses (but don’t ignore risks inherent in collection)  At least experiment with different frameworks for protecting privacy in research using clinical data  Rely less on consent and instead pursue other models of patient engagement (e.g., input into research; greater transparency re: research uses of data; requirements to share results with patients)  Mechanisms of accountability/oversight (Canadian model (PHIPA), voluntary research network governance models, accreditation)  Incentives to pursue privacy-enhancing data sharing architectures  Study their efficacy in building and maintaining public trust in research.
  16. 16. White House Big Data Report  Released May 2014  Distinction between “big data” and “small data”: Big data is characterized by 3 Vs (Volume, Variety, Velocity)  Other key observations:  De-identification is insufficient to protect privacy in big data analytics  Meta data raises significant privacy issues – should not necessarily treat as less risky then content  Focus on assuring responsible uses, vs. trying to control collection; role of notice and consent should be re-examined.
  17. 17. White House Big Data Recommendations*  Current policy frameworks may work well enough for small data, but they do not meet the challenges of big data, including in health:  “The complexity of complying with numerous laws when data [is] combined from various sources raises the potential need to carve out special data use authorities for the health care industry if it is to realize the potential health gains and cost reductions that could come from big data analytics.” (p. 23)  Government should lead a consultative process to assess how HIPAA and other relevant federal laws and regulations can best accommodate the advances in medical science and cost reductions in health care delivery enabled by big data. *partial list
  18. 18. White House Big Data Recommendations  Advance the Consumer Privacy Bill of Rights, including drafting of legislative text  Pass national data breach legislation  Government data is a national resource and should be made broadly available to the public whenever possible – while continuing to protect personal privacy, business confidentiality and national security.  All departments and agencies should examine how they might best harness big data to help carry out their missions.  We should increase investment in R&D on privacy-enhancing technologies.
  19. 19. PCAST Big Data Technology Report  Policy attention should focus more on the actual uses of big data and less on its collection and analysis.  Policies & regulation should not embed particular technological solutions but should instead focus on intended outcomes.  Relevant gov’t agencies (NITRD) should strengthen research in privacy-related technologies & relevant areas of social science that inform their application.  US should encourage increased education and training opportunities in privacy protection.  U.S. should take the lead by adopting policies that stimulate the use of privacy- protecting technologies that exist today.

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