Patient data for companies: Patient privacy, private profits and the public good

By Adrian Thorogood and Eva Winkler.

Our paper tackles a question that policymakers and public healthcare systems are wrestling with around the world: should for-profit companies be given access to medical data derived from patients for research?

In public healthcare systems, medical data is generated as part of the routine care of patients, and through administrative processes like billing and reimbursement. Medical data is a valuable resource for research and innovation that can advance medical science and improve healthcare. Beyond academic research, for-profit companies are increasingly interested in access to “real world” medical data to inform the discovery and development of drugs, medical technologies, and data-based health applications such as AI. Many countries are actively promoting data sharing to advance public health and wealth goals.

Despite this enthusiasm, for-profit re-use of medical data from public healthcare systems continues to be a source of controversy. Hospitals and data sharing initiatives have often been criticized for a lack of transparency and social license. Some have even been shuttered or sued. Empirical surveys consistently suggest patients and members of the public are less comfortable with companies accessing their sensitive health information than healthcare professionals or academic researchers.  This tension between the interests of patients and those of the public and for-profit corporations calls for a closer look at the interests of all parties involved.

Inspired by political philosophy, our paper aims to identify and evaluate the competing claims of different stakeholders relating to for-profit re-use of medical data. This includes the patients providing data, the companies seeking to use data, the society who funds and relies on its public healthcare system, and the healthcare institutions and professionals who painstakingly generate medical data.

Patients have a right to have their medical data treated with confidentiality, and a right to actively determine who accesses this sensitive form of personal data and why. Any re-use of their data should be subject to strict privacy and security safeguards, and to high standards of consent, transparency, and accountability. Patients might expect to receive a direct share in profits generated from the contribution of data. Assuming such a scheme could be practically implemented, does this claim override those of companies, hospitals and society? We argue that this is a weak claim: while medical data certainly fall under patients’ control required by the right to informational self-determination, data are generated primarily for their healthcare and no right to share in profits  can be deduced.

For-profit companies in the health sector do not have a right per se to access publicly funded medical data. However, they are entitled to freedom of research – a defensive right restricting state influence on research activities – and a right to a level playing field where access is provided (non-discriminatory access). Companies do have a legitimate right to pursue and realize profits from developing high-quality, life-saving or improving health products. Where products do not offer true value, are overpriced or are not domestically available, however, commercial practices can threaten the sustainability of health systems and patient access. This seems all the more unjust for products developed using data provided by health systems and patients. As part of corporate social responsibility, companies have ethical and reputational reasons to protect patient privacy and to deliver benefits to society, reflected by the current proliferations of guidelines around responsible AI.

Hospitals and clinics are ultimately the places where patient data is generated, through the dedicated efforts of healthcare professionals and staff. Do physicians and hospital leadership own the data and have a claim to share in eventual profits? These claims are complicated by the public funding supporting healthcare delivery, patient self-determination, and the fact that data generation is only the beginning of a complex value chain. They do, however, have a valid claim to appropriate compensation for data generation and curation, one that is all too often overlooked.

Society can benefit from for-profit re-use through things like improved drug safety, as well as more accurate and cost-effective care. How can the  state ensure public funds invested in health systems and data infrastructure maximally benefit society, while also maintaining public and patient trust?

Two key tensions arise: between profit maximation versus societal benefit, and between commercial and societal interests in exploiting data versus patient self-determination and privacy. To address these tensions, we conclude by suggesting conditions for ethically sound for-profit re-use of medical data:

  • Limit for-profit re-use to uses that aim to improve health or health systems and ensure and document this return and contribution in a transparent way.
  • Strengthen consent practices and offer patients meaningful consent opportunities, supported by data access oversight bodies including patient representatives.
  • Establish privacy and security safeguards to minimize risks and hold companies to account for breaches.
  • Transparently document public support for companies, and track how this contributes to profits and societal benefit.
  • Explore mechanisms to encourage alignment between company and societal aims (e.g., fair licensing and pricing commitments, preferential health system access).

We conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to advance the public interest in better healthcare.

 

Paper title: Patient data for companies? – An ethical framework for sharing patients’ data with for-profit  companies for research

Authors: Winkler EC1, Jungkunz M2, Lotz V1, Thorogood A3, Schickhardt C2

Affiliations:

  1. University Hospital Heidelberg, Section for Translational Medical Ethics, Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany
  1. German Cancer Research Center, Section for Translational Medical Ethics, National Center for Tumor Diseases, Heidelberg, Germany
  2. Terry Fox Research Institute, Vancouver, BC, CAN

Competing interests: ECW and CS have been receiving grants by the German Ministry of Education and Research (BMBF) in the frame of the German Medical Informatics Initiative (MII) and have been involved in the Working Group “Consent” of the MII

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