Patients’ Duties to Share Data– Because They Benefitted from the Data of Others

1. Patients’ Duties to Share Data– Because They Benefitted from the Data of Others ELSI-LHS University of Michigan Department of Learning Health Sciences November 15, 2017 Kenneth W. Goodman, PhD, FACMI Professor of Medicine and Philosophy Director, University of Miami Miller School of Medicine Institute for Bioethics and Health Policy Director, WHO Collaborating Center in Ethics and Global Health Policy kgoodman@med.miami.edu

2. Foundations Clinical and population health science have always been • Information-intensive • Able to presume the consent of its beneficiaries • Utilitarian

3. Summary of the 3 Vs of Big Data and Their Implications Mooney SJ et al. Epidemiology in the era of big data. Epidemiology 2015;26(3):390-394, doi:  10.1097/EDE.0000000000000274

4. Privacy vs. Science? • Privacy and confidentiality were never seriously considered to be hard barriers to sharing and analysis • Biomedical research has long relied on the work of trusted entities to collect health information; thus • Security, de-identification, anonymization, pseudonymization

5. Vague Nomenclature We are poorly served by frequently used terms: • “Cloud” is a metaphor • “Data” is used sloppily; we might mean “information” or “knowledge” • “Share” is inadequate to the task • “Big Data” is overused and imprecise

6. Big Data and LHS Ethical concerns should focus on • Decision support – given variable data and data base quality, uncertainty, etc. • Appropriate uses and users • Data sharing and interoperability

7. 5 mb, 1956

8. This is not to say … … that concerns about consent, privacy, confidentiality, stigma, etc. are not worthy of attention. It is to suggest that Learning Health Systems, all other things being equal, raise no new ethical challenges.

9. Privacy • Is not an absolute right • Must therefore be balanced against other rights (including a “right to benefit from science”*) • Is often mistakenly invoked by individuals * http://www.ohchr.org/EN/Issues/CulturalRights/Pages/benefitfromscientificprogress.aspx

10. Information Free-Riders • Emphasize privacy over public health • Risk little if anything • Benefit from others’ contributions of information

11. Analogues • Vaccine refusers • Organ donation refusers • Infrastructure support refusers

12. ↑ Health ≠ ↓Privacy • Smart laws and policies • Recognition of duties to collectives • Learning healthcare systems • Public health analogue of “duty to treat” • Trust

13. Role of Ethics • Illuminate the force, scope and limitations of rights • Identify and balance conflicting rights, and rights and duties • Identify and justify duties

14. Precedents • Hurricane forecasting • Pandemics • Environmental toxins

15. Patients’ Duties to Share • Explore concepts of “tacit” and “latent” consent • Be explicit that all people – not just investigators – have duties to share • Improve security • Earn trust

16. Management, Governance • Balance data, consent, privacy • Identify best practices • Develop revised IRB-like review entities, and • Build consultation capacity for risk communication, decisions under uncertainty

17. Patients’ Duties to Share Data– Because They Benefitted from the Data of Others ELSI-LHS University of Michigan Department of Learning Health Sciences November 15, 2017 Kenneth W. Goodman, PhD, FACMI Professor of Medicine and Philosophy Director, University of Miami Miller School of Medicine Institute for Bioethics and Health Policy Director, WHO Collaborating Center in Ethics and Global Health Policy kgoodman@med.miami.edu