Big Data in Health Care: Rewards and Risks. Daniel J. Weissburg, JD, CHC, Privacy Officer, UW Health Molly R. Berkery, JD, MPH, Godfrey & Kahn, S.C.

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1 Big Data in Health Care: Rewards and Risks Daniel J. Weissburg, JD, CHC, Privacy Officer, UW Health Molly R. Berkery, JD, MPH, Godfrey & Kahn, S.C.

2 Outline Big Data in Health Care Impetus Benefits & Potential Outcomes Research and Development Initiatives Regulation Challenges

3 Impetus for Big Data in Health Care

4 Impetus United States Health Care Costs Per capita national health expenditures: $9,255 (2013) Total national health expenditures: $2.9 trillion (2013) Total national health expenditures as a percent of Gross Domestic Product: 17.4% (2013) Health care delivery Fee-for-service -> value-based Clinical trends Pharmaceutical and medical device industry Potential monetary value to the US health care system Centers for Disease Control and Prevention, Health Expenditures, 2013.

5 Potential Benefits & Outcomes of Big Data in Health Care

6 Benefits of Big Data in Health Care Increase transparency Improve patient outcomes Nuances in subpopulations may be so rare that they are not readily apparent in small samples Predictive analytics Reduce health care costs Research and development Pharmaceutical and medical device industry Smart phone applications

7 Examples of Early Successes The University of Ontario s Institute of Technology developed predictors of the onset of nosocomial infections of neonatal intensive care newborns. Brigham and Women s Hospital in Boston developed standardized knee joint-replacement surgery. Kaiser Permanente connected clinical and cost data leading to the discovery of adverse drug effects and the subsequent withdrawal of the drug Vioxx from the market. Johns Hopkins School of Medicine - data from Goggle Flu Trends allowed prediction of surges in flu-related emergency room visits a week prior to other sources.

8 Research and Development Initiatives

9 United States Office of Science and Technology Policy (OSTP) Goal: Make the most of the fast growing volume of digital data. Transform the use of big data for scientific discovery. Environmental/Biomedical research. Education and national security. Six federal departments and agencies committed $200M: To advance, analyze, and share big data. To harness the technology to increase discovery rates. To expand the workforce using and developing these technologies.

10 Innovation GPS-enabled asthma inhaler GPS-enabled tracker that records inhaler usage by asthmatics (data merged with CDC data on asthma catalysts to assist with the development of personalized treatment plans and spot prevention opportunities). Behavioral health smart phone app Ginger.io uses information from a patient s smartphone app to help providers manage patient care and detect changes in behavior and health. Physical activity tracker the new medical device? Spire an app that senses and tracks physical movement, position and breathing patterns to help individuals boost activity, relaxation and focus. Spire has considered getting FDA approval as a true medical device.

11 Regulation of Big Data

12 Regulation of Big Data Is health care behind in the big data revolution due to regulatory hurdles? The Health Insurance Portability and Accountability Act of 1996 ( HIPAA ) Breach Notification Rule Blanket prohibition on the sale of PHI (with specific exceptions) Prohibition of compound authorization (with specific exceptions) De-identification requirements The Health Information Technology for Economic and Clinical Health ( HITECH ) Increases the scope of privacy and security of health information under HIPAA. Increases the potential legal liability for non-compliance and provides more enforcement of HIPAA rules.

13 Regulation of Big Data Affordable Care Act Meaningful use incentives [e]lectronically capturing health information in a standardized format and [i]nitiating the reporting of clinical quality measures and public health information. rigorous health information exchange, [e]lectronic transmission of patient care summaries across multiple settings, and "patient-controlled data. access to comprehensive patient data through patient-centered [health information exchange].

14 Regulation of Big Data Other legal considerations Mobile health uses of big data and FDA regulation Genomic and biometric big data Health insurance and discrimination Government use of big data State law considerations Ethical considerations Research ethics

15 Challenges

16 Compliance Challenges Technical Institutional Operational Legal

17 Data Breaches Not a new issue Growing level of patient awareness & fear Cyber-risk liability and insurance Privacy/Security issues Lack of safeguards of protected health information. Lack of administrative safeguards of electronic protected health information. Use of public cloud services.

18 Largest (Health Care) Breach - Office for Civil Rights, US Dept. of Health and Human Services

19 Top 10 Health Care Provider Breaches

20 Top 10 Health Care Provider Breaches

21 New York Presbyterian Hospital/Columbia University College of Physicians and Surgeons A CASE STUDY

22 NY Presbyterian/Columbia Columbia University College of Physicians and Surgeons: 655 Students $1.46 billion annual budget $1.6 billion endowment First MD graduate in 1769 New York Presbyterian Hospital: 2,478 beds (six locations) $4.3 billion annual revenue (2013) 6 th on America s Best Hospitals (U.S. News)

23 NY Presbyterian/Columbia Physician had a personally-owned computer server on the network containing NYP patient PHI. Due to a lack of technical safeguards, PHI was accessible on internet search engines, including Google. An individual found the PHI of their deceased partner, a former patient of NYP, on the internet and complained. Breach report to HHS Office for Civil Rights (OCR) regarding the disclosure of the PHI of 6,800 individuals, including patient status, vital signs, medications, and laboratory results.

24 NY Presbyterian/Columbia Neither entity: made efforts prior to the breach to assure that the network was secure and that it contained appropriate software protections. had conducted an accurate and thorough risk analysis that identified all systems that accessed PHI. had developed an adequate risk management plan that addressed the potential threats and hazards to the security of PHI. NYP failed to implement appropriate policies and procedures for authorizing access to its databases and failed to comply with its own policies on information access management.

25 NY Presbyterian/Columbia NYP and Columbia agreed to settle charges that they violated HIPAA NYP paid $3.3 million Columbia paid $1.5 million LARGEST HIPAA SETTLEMENT TO DATE (5/2014)

26 NY Presbyterian/Columbia Both NYP and Columbia agreed to a 3 year Corrective Action Plan, which includes: Undertaking a risk analysis Developing a risk management plan (submitted to the OCR for approval) Revising policies and procedures (submitted to the OCR for approval) Training staff (within 30 days and annually) Providing incident and annual progress reports to the OCR Deep violation of patient privacy Massive reputational harm to both entities High cost of privacy/data security compliance, on a compressed time table

27 Strategic Prosecution Data breaches are a risk for all HIPAA Covered Entities. But if you are big, famous and renown, with words like University of Wisconsin in your name High profile means big headlines, and big headlines have big impact, and big impact is what government enforcers want.

28 Wisconsin

29 Wisconsin

30 Wisconsin

31 Additional Security Concerns Cyber-attacks the number one cause of data breaches, and typically multi-staged attacks. Cloud computing begins with social engineering.

32 Questions

33 Contact Information Daniel J. Weissburg, JD, CHC Compliance Officer - UW Hospitals Privacy Officer - UW Health University of Wisconsin Hospitals and Clinics Authority Molly R. Berkery, JD, MPH Attorney Godfrey & Kahn, S.C.

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