By Seyed Amir Ahmad Safavi-Naini

In an age where artificial intelligence (AI) is transforming medicine, patient data is more valuable than ever. Open-access initiatives have revolutionized research by fostering collaboration and accelerating innovation. However, they also pose profound ethical challenges, particularly regarding patient consent and the commercialization of data. As we navigate this complex landscape, it is essential to ask: Are our current data-sharing practices truly respecting the trust patients place in us?

Open-access medical data has undoubtedly propelled AI-driven research forward, enabling groundbreaking discoveries in diagnostics, treatment, and personalized medicine. However, the widespread availability of patient data raises fundamental ethical concerns. Patients contribute their data with the expectation that it will serve the greater good, not necessarily to fuel commercial enterprises. The unrestricted licensing of such data often conflicts with their expectations, exposing an ethical rift between scientific progress and patient rights.

During a research project that involved direct patient communication, it was found that many individuals were uncomfortable with their medical data being used for profit without their explicit consent. This concern was even more pronounced among those who had personally contributed to the costs of their medical care. These insights highlight the urgent need for a patient-centered approach to data-sharing protocols.

The commercialization of medical data presents a paradox. On one hand, industry partnerships drive innovation, improve healthcare outcomes, and enhance AI capabilities. On the other, these arrangements raise critical concerns about privacy, autonomy, and potential exploitation. While regulatory frameworks such as HIPAA in the U.S. and GDPR in the EU provide legal safeguards, they often fail to address the nuances of patient consent in a commercialized data-sharing ecosystem.

A case in point is our experience with the PanCanAID project, an AI-driven initiative aimed at early pancreatic cancer detection. We collected data from 1,500 participants and engaged directly with over 200 patients to discuss their perspectives on data sharing. While many supported the use of their data for scientific advancement, there was significant resistance to unrestricted commercial use, even when data was anonymized. These concerns reflect a broader issue: the ethical tension between open-access policies and the expectations of the very individuals who provide this invaluable data.

Efforts to publish our dataset in a prominent medical imaging repository brought this ethical dilemma into sharp focus. The repository mandated that all data be shared under fully open licenses, such as Creative Commons CC0 or CC-BY, which permit unrestricted commercial use. This requirement was at odds with patient preferences, many of whom wanted assurances that their data would not be freely used for profit-driven activities.

In response, we proposed an alternative licensing model requiring that 10% of revenue generated from data use be directed toward pancreatic cancer research and charities. This proposal was rejected due to governance and enforcement challenges. This experience underscores the need for more flexible and ethically sound data-sharing frameworks, ones that consider both the scientific imperative for open access and the moral obligation to honor patient trust.

To reconcile innovation with ethical responsibility, several strategies merit consideration:

• Explicit Informed Consent – Patients should be given clear, detailed options regarding how their data will be used, including potential commercial applications. Patients should receive a form at the time of care delivery asking for permission to use their data, specifying the type of data and the purposes (research/non-for-profit/industry).
• Revenue-Sharing Models – A percentage of profits from data-driven discoveries should be reinvested into research, patient care, or public health initiatives.
• Blockchain and Smart Contracts – These technologies can facilitate transparent, enforceable agreements that ensure ethical data use while safeguarding patient consent.
• Watermarking and Tracking – Embedding digital markers in datasets can help monitor and regulate data use, ensuring compliance with ethical guidelines.

As AI and big data continue to revolutionize medicine, the ethical management of patient data is more pressing than ever. Open access and scientific progress must not come at the cost of patient autonomy and trust. Our experience highlights the urgent need for repositories, researchers, and policymakers to reconsider data-sharing licenses and implement practical, ethical solutions that balance accessibility with responsibility.

The medical and research communities are encouraged to participate in this discussion and contribute to shaping a future that upholds patient trust while maintaining the progress of medical innovation.

Author: Seyed Amir Ahmad Safavi-Naini, MD-MBA

Affiliations: 

• Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
• Division of Data-Driven and Digital Medicine (D3M), Icahn School of Medicine at Mount Sinai, New York, United States

Competing interests: None declared