1. Privacy and Security Workgroup: Big Data Public Hearing November 10, 2014 Deven McGraw, chair Stan Crosley, co-chair

2. Agenda 1.Big data topics – Discuss possible topics for big data listening sessions 2.Anticipated Hearing Dates / Format 3.Potential Panelists – Create a list of potential panelists 2

3. Main Topic Areas 3 Health Big Data Opportunities Learning Health System Health Big Data Concerns / Harms Protections for Consumers Current Law

4. Big Data Topics 1.Health Big Data opportunities: some snapshots of what’s happening out there, potentially exploring: – Clinical data combined with consumer-provided data to improve individual and population health; – Genomic data – Innovative uses of device data; – PCORI initiatives; – Transparency, performance measurement – Mobile app/social networking site data, etc. – Use of non health data for health purposes (e.g., inferences) 4

5. Big Data Topics 5 Analytics Lots of information in anonymized state Precision Medicine Must identify particular patient; longitudinal health record What can be done without identifying an individual patient v. what can be done when the patient is identified? 2.Learning Health System: 2 Buckets

6. Big Data Topics 6 3.Health Big Data Concerns/Harms: discuss the potential harms with use of health big data, ideally based on some real examples (civil rights / discrimination; economic; reputational)

7. Big Data Topics 4.Protections for consumers: – Anonymization/de-identification techniques and their limitations – Explicit prohibition on re-identification? – individual choice/consent and its limitations – Appropriate use limitations 5.Current law: what does it cover and where are the gaps? 7

8. Anticipated Hearing Dates / Format 8 Anticipated hearing dates: December 5 and 8 Big data hearing topics: Amend topics? Additional topics? Format: One panel per topic? Number of panelists? 5-10 minute presentation followed by discussion?

9. Potential Panelists 9 1.Health Big Data Opportunities 2.Learning Health System 3.Health Big Data Concerns / Harms 4.Protections for Consumers 5.Current Law