HHS stands up new office for artificial intelligence, cybersecurity, and health technology policy functions

With artificial intelligence (AI) at the forefront of a global conversation regarding its uses, particularly within the healthcare and life sciences industries, the US Department of Health and Human Services (HHS) recently announced a reorganization of the role and function of the Assistant Secretary for Administration (ASA) to consolidate and streamline AI, cybersecurity, data, and health technology policy functions within the department and its agencies.

Historically, the responsibility for policy and oversight of these functions was spread across the Office of the National Coordinator for Health Information and Technology (ONC), the ASA, and the Administration for Strategic Preparedness and Response (ASPR).

Reorganization

In this reorganization, the technology and data policy and strategy functions of the ASA, including the HHS-wide roles of Chief AI Officer, Chief Data Officer, and Chief Technology Officer, are shifting to ONC.

Through this reorganization, HHS will rename ONC as the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology, or ASTP/ONC.
With this reorganization and creation of ASTP/ONC, the US Food and Drug Administration (FDA) states that its Center for Devices and Radiological Health’s (CDRH) regulation of AI-enabled medical devices will continue to prioritize assuring the safety and effectiveness of medical devices as HHS implements its AI restructuring.

CDRH is expected to maintain its authority and responsibility to oversee medical devices, including those that are AI-enabled and as products evolve to feature generative AI. CDRH will be one of the offices that will coordinate with the Chief AI Officer and the other new ASTP/ONC officials.

New roles

ASTP/ONC serves as the new home for AI policy functions as a staff division within HHS. The Office of the Chief AI Officer, Office of the Chief Data Officer, and a newly recreated Chief Technology Officer will move to be under ASTP/ONC.

The ASTP/ONC offices will carry out implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act and the 21st Century Cures Act, as well as other interoperability efforts previously spearheaded by ONC.

With this reorganization and designation of these new roles, we will continue to monitor developments within the AI healthcare space and any corresponding rulemaking, as the industry will need to adapt to the AST/ONC’s initiatives.

The current National Coordinator, Micky Tripathi, will be named Assistant Secretary for Technology Policy/National Coordinator for Health Information Technology. Assistant Secretary Tripathi has also been named as the ASTP/ONC’s Acting Chief AI Officer.

According to HHS, the Chief AI Officer will set AI policy and strategy for the department; establish internal governance, policies, and risk management approaches for uses of AI internal to HHS; coordinate HHS’s AI approach in the health and human services sectors; support the safe and appropriate use of AI technologies and tools across the department; and coordinate AI-related talent and training initiatives.

The Chief Data Officer will continue to oversee data governance and policy development, drive data literacy and data talent initiatives, manage the HHS data strategy, support data collaboration and exchange, and manage HHS’s data as a strategic asset for the department.

ASTP/ONC will establish an Office of the Chief Technology Officer and reinstitute the role of Chief Technology Officer, who will be responsible for overseeing department-level and cross-agency technology, data, and AI strategy and policy.

Takeaways

With this reorganization and hiring of new federal government roles, HHS is expected to continue developing and prioritizing its AI health policies and objectives.

The healthcare industry is grappling both with the promise and risk of AI tools and will look to the federal government for guidance in the development and use of such tools in a safe and ethical manner.

We will continue to review these and other initiatives in the AI space, including its use and impact on the healthcare and life sciences industries.

For more information, please contact your DLA Piper relationship attorney, the authors of this alert, or any member of DLA Piper’s AI and Data Analytics practice, Government Affairs and Public Policy practice, Healthcare industry group, or our Life Sciences industry group.