The existing data protection laws hinder the efficient use and combination of "big" (anonymized, clinic-owned) and "small" (non-anonymized, individually owned) health data. We suggest a framework to make the combination of big and small health data in an individualized health data bank possible and acceptable to patients, health care providers, politicians, and the public at large. Such an infrastructure is needed for the inclusion of real life health outcome measures for determining the effects of treatments.
In: Kaplan, B., Davidson, E.J., Demiris, G., Schreiber, R., Waldman, A.E., "Rethinking Health Data Privacy," Proceedings of the American Medical Informatics Association Annual Symposium, Washington, DC, November 2019
In: Yale University Institute for Social and Policy Studies Working Paper 14-028; The Challenges of The Digital Era: Privacy, Information and More, ed. S. Yanisky-Ravid, New York: Fordham University Press, (forthcoming, 2017), chapter accepted, but book never published
The use of data in medical research that was originally collected for different purposes, known as secondary data, is an effective way to conduct reliable and cost-effective studies so as to progress knowledge in medicine. A number of serious practical, ethical and legal issues and concerns about this process exist, however. Ensuring a high level of data quality is imperative to produce reliable results, and researchers may face accessibility problems. Projects designed to alleviate these issues are underway, however, lowering the cost and increasing the access to secondary data even further. Although secondary data is de-identified to protect the confidentiality, ethical problems of individual rights versus the benefit of society persist, leading some to call for a new 'macroethics' surrounding data use. Legislation to this end has been introduced in many countries, but issues relating to the exemptions it offers and its interpretability remain. To ensure that the use of secondary data in medical research can continue to accelerate the pace of development in medicine, a global effort involving technological and ethical standardization needs to be developed.
AbstractIt has become a trope to speak of the increasing value of health data in our societies. Such rhetoric is highly performative: it creates expectations, channels and justifies investments in data technologies and infrastructures, and portrays deliberations on political and legal issues as obstacles to the flow of data. Yet, important epistemic and political questions remain unexamined, such as how the value of data is created, what data journeys are envisioned by policies and regulation, and for whom data types are (intended to be) valuable. Drawing on two empirical cases, (a) interviews with physicians on the topic of digital selfcare, and (b) expectations of stakeholders on the use of Real-World Data in clinical trials, as well as existing literature, we propose a typology of what health data help us to do. This typology is intended to foster reflection about the different roles and values that data use unfolds. We conclude by discussing how regulation can better accommodate practices of valuation in the health data domain, with a particular focus on identifying regulatory challenges and opportunities for EU-level policy makers, and how Covid-19 has shed light on new aspects of each case.
It has become a trope to speak of the increasing value of health data in our societies. Such rhetoric is highly performative: it creates expectations, channels and justifies investments in data technologies and infrastructures, and portrays deliberations on political and legal issues as obstacles to the flow of data. Yet, important epistemic and political questions remain unexamined, such as how the value of data is created, what data journeys are envisioned by policies and regulation, and for whom data types are (intended to be) valuable. Drawing on two empirical cases, (a) interviews with physicians on the topic of digital selfcare, and (b) expectations of stakeholders on the use of Real-World Data in clinical trials, as well as existing literature, we propose a typology of what health data help us to do. This typology is intended to foster reflection about the different roles and values that data use unfolds. We conclude by discussing how regulation can better accommodate practices of valuation in the health data domain, with a particular focus on identifying regulatory challenges and opportunities for EU-level policy makers, and how Covid-19 has shed light on new aspects of each case.
