Key Takeaways | Data Rights Between Health Systems and Affiliated Universities | McDermott

Key Takeaways | Data Rights Between Health Systems and Affiliated Universities

Overview



The right to use and share healthcare data is often fraught with complex privacy, intellectual property, and strategic considerations. For affiliated universities and health systems, these issues can be particularly pronounced. The demand for healthcare data in AI development and training, research, and other secondary purposes has also accelerated the need for a considered approach. During this webinar, our speakers discussed essential healthcare data rights and related issues that universities and affiliated health systems should address with respect to leveraging healthcare data.

Top takeaways included:

  1. Establishing a streamlined and consistent process for data sharing between health systems and affiliated universities can prevent delays and compliance issues. Stakeholders often face significant delays in accessing data, which can lead to start-up delays for clinical trials and other research. Implementing a standing process, such as a master-level agreement, can help address these challenges by providing a predefined process for data sharing.
  2. Data governance is essential to ensure that data sharing aligns with the missions and strategic objectives of both health systems and universities. There are other considerations for data governance beyond regulatory issues, including the critical question of whether data should be shared even if legally permissible. In addition, to ensure a comprehensive and aligned approach, data governance should intersect with other processes and policies, such as IRB review, AI governance, and intellectual property.
  3. Commercializing de-identified data can provide economic value but requires careful negotiation of revenue sharing and compliance with legal standards. HIPAA does not regulate de-identified data, and it can be a valuable commercial asset. When negotiating a revenue sharing agreement, it is crucial to address the scope of permitted uses of de-identified data and ensure compliance with healthcare fraud and abuse laws such as the Anti-Kickback Statute and the Stark Law.

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