A paper published in the Nature Medicine on 7 January 2019 outlines the legal and ethical challenges that big data brings in terms of patient privacy. Topics discussed include the concept of health privacy, the importance of equity, consent, and patient governance in data collection, discrimination in data uses, how to handle data breaches and possible ways forward for the regulatory system.
Rapid development of machine-learning techniques and artificial intelligence has promised to bring forth even more useful applications from big data. But with big data comes big risks and challenges, among them significant questions about patient privacy.
W. Nicholson Price II of the University of Michigan Law School, Ann Arbor, MI, and I. Glenn Cohen of the Harvard Law School, Cambridge, MA, USA, both engaged in the Project on Personalized Medicine, Artificial Intelligence, & Law, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Cambridge, MA, USA and the Center for Advanced Studies in Biomedical Innovation Law, University of Copenhagen, Copenhagen, Denmark examine in their paper ethical concerns and legal responses raised.
In particular, they discuss the benefits that big data may bring to health science and practice and then turn to the concerns that big data raises in these contexts. They focused on a prominent, but not the only, worry of privacy violations. They presented a basic theory of health privacy and examined how privacy concerns play out in big data’s application to health care in terms of data collection and data use.
The authors ground these concerns in a discussion of relevant law, a key feature of the health data world faced by innovators in this space and made some regulatory recommendations. They argued that while too little privacy raises concerns, it is also true that too much privacy in this area can pose problems.
The authors elaborate on how to think about health privacy, gathering data in terms of custodian-specific versus blanket provisions, equitable data collection, the role of the patient in data collection and access, as well as data uses, in particular, discrimination based upon health data and sharing of private information. They conclude with their proposal for a path forward.
The research reported in this publication was done with the support of Collaborative Research Program for Biomedical Innovation Law. It is a scientifically independent collaborative research programme supported by a Novo Nordisk Foundation Grant. W. Nicholson Price II’s work was also supported by the US National Cancer Institute grant in The Lifecycle of Health Data: Policies and Practices.
Price WN 2nd, Cohen IG. Privacy in the age of medical big data. Nature Medicine 2019; 25(1):37-43.