How To Protect Your Health Data From Being Used For Research
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1 Big Data: Research Ethics, Regulation and the Way Forward Tia Powell, MD AAIC Washington, DC, 2015
2 1854 Broad Street Cholera Outbreak
3 Federal Office of Personnel Management Data Breach, 2015 Well-known security flaws All applicants for background check 15 years Vast trove of data Name, DOB Social security numbers fingerprints 21.5 million individuals records hacked
4 Ethics question: How do we devise policies that facilitate the harvest of knowledge from big data while protecting individual privacy, and respecting individual preferences?
5 What are challenges to finding right answer? 1) inherent tension between easy flow of data for research and restrictions that protect privacy 2)Regulation is blunt instrument Broad concerns about privacy, data use Research context swept into larger problems May lead to wrong answer for research
6 What s different in today s data? Big Data: volume storage analysis Multiple sources Electronic Medical Record (EMR) Data bases: ADNI, Biobanks, RHIOs Social Networks, Market Data, Websearch Financial, Personnel, Government
7 How is big data used? Multiple purposes Medical/public health research Marketing Insurance Government surveillance (Snowden) Financial risk assessment (credit score)
8 Uneasy Beginnings: big data, privacy and regulation 1997 release of de-identified Massachusetts employee records to facilitate research Latanya Sweeney re-identifies using voter registration data Presents Governor Weld his personal health record Shapes HIPAA legislation
9 US Protections for PHI: HIPAA and HITECH HIPAA 1996: First major federal legislation to specify protections for sharing personal health information De-identification of individual information: removal of 18 specific items HITECH: 2009 addition Required reporting of data breaches >500 pts
10 Security breaches of EMR Using required public report of PHI data breaches for > 500 Patients: 29 million medical records breached breaches >1 million records Trend is toward more, not fewer breaches Most common mode: inappropriate storage of patient data on personal laptop Liu, JAMA 2015
11 Could re-identification of individuals within large data set happen today? Much more difficult HIPAA precludes use of name, DOB, full zip code, address 2010 HHS study: 2/15,000 patients reidentified But still possible Social media: DOB, schools, jobs, SS#: not randomly generated
12 Participant preferences for data use: Vary widely by region, nation Many willing to give data for med research Strong wish for consent, privacy protections Consent varies by: who holds data: hospital, corporation, govt Purpose: cure dx, marketing, surveillance Kim, JAMIA 2015
13 General Data Protection Regulation Pending EU legislation, hotly debated Added restrictions for big data collection Without strong exemptions for medical research May require re-consent for many legacy repositories Possible impediment to international collaboration Significant implications for genetic, big data medical research
14 Scientists should not neglect privacy, security, consent
15 Global Alliance for Genomics and Health International group of researchers, patient advocates, bioethicists, privacy experts Goal is to develop best practices for both sharing and protecting research data, especially within genetics Publically available consent policies, forms, white papers
16 Best practices and recommendations for big data and research: Build public trust, respect values Focus on consent, controlled access, privacy Rigorous security Distinguish medical research repositories, purpose, from other uses
17 References and contact info Global Alliance for Genomics and Health: genomicsandhealth.org Haselgrove, Poline, Kennedy; A Simple Tool for Neuroimaging Data Sharing, Frontiers in Neuroinformatics, 2014:8(52):1-10. Kim, Joseph, Ohno-Machado; Comparison of Consumer Views on electronic data sharing, Journal American Medical Informatics Association, 2015:22: Liu, Musen, Chou; Data Breaches of Protected Health Information in the US, JAMA 2015;313(14): Contact Info: Tpowell@montefiore.org
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