Governance and Use of Patient Data in Health IT Products

There has been huge growth and large expectations for the use of patient data in health care, particularly as an adjuvant to clinical decision-making. From image interpretation to diagnosis, payer, provider and life science companies are forming partnerships with technology and data analytics companies to develop new tools and capabilities. However, payer, provider and life science companies face potential public backlash and regulatory scrutiny over data privacy concerns when engaging outside partners to analyze PHI and non-PHI data, and use of patient data in new ways may create health disparities and pose other ethical challenges for payer, provider and life science companies. While the FDA regulates AI tools that are used in diagnosis or treatment, the lack of guidelines for how AI should be developed, how patient data should be used, how AI is applied to various populations (e.g., across races or age groups) and how AI intellectual property is handled puts payer, provider and life science companies at risk. The goal of this Work Group is to articulate standards for responsible innovation to shape the partnerships between payer, provider and life science companies and developers of AI and other analytics and to guide the product development process of data tools for the clinical setting.