On July 25, the Department of Health and Human Services (HHS) announced a number of organizational changes, including renaming the Office of the National Coordinator for Health Information Technology (ONC) to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC), among other actions. These organizational changes reflect heightened focus to provide oversight and issue policies governing the use of individuals’ health data and the development of artificial intelligence (AI) technologies. It also demonstrates HHS’ aim to address recent cyberattacks against the healthcare sector entities.

Background and Summary of Changes

Since its inception in 2004 and formal creation of the office in 2005, ONC has led efforts to promote the development, application, and use of health information technology (IT). In 2009, Congress enacted legislation which established ONC in statute and promoted the adoption and meaningful use of health IT and the adoption of standards and a voluntary health IT certification program. According to an ASTP/ONC blog, HHS has reorganized ASTP/ONC in order to consolidate organizational resources and reinforce the importance of oversight over health IT policy as part of HHS’ mission.

Specifically, HHS’ reorganization includes the following changes:

1. Rename ONC to the ASTP/ONC and transfer oversight over technology, data, and AI policy and strategy from the Assistant Secretary for Administration (ASA) to ASTP/ONC. HHS states that ASTP/ONC will continue as a staff division within HHS. It will have increased responsibilities and new staff and funding during the transition. A notice published in the Federal Register outlines the responsibilities of the various offices and positions included in ASTP/ONC. In addition to these changes, National Coordinator Micky Tripathi will be named ASTP/National Coordinator for Health Information Technology. As directed in the President’s Executive Order on Safe, Secure, and Trustworthy AI (see our client alert here), Assistant Secretary Tripathi has also been named the Department’s Acting Chief AI Officer until the permanent position is filled.
2. Announce recruiting for several HHS-wide roles, including Chief Technology Officer, Chief Data Officer, and Chief AI Officer. ASTP/ONC will establish an Office of the Chief Technology Officer, which will include the Office of the Chief AI Officer, Office of the Chief Data Officer, and a new Office of Digital Services. The role of Chief Technology Officer will oversee Department-level and cross-agency technology, data, and AI strategy and policy. The Chief AI Officer will set AI policy and strategy for HHS and establish internal governance, policies, and risk management approaches for uses of AI internal to HHS while the Chief Data Officer will continue to oversee data governance and policy development and manage the HHS data strategy. ASTP/ONC is currently recruiting for these positions.
3. Bolster federal efforts to address health sector cybersecurity. HHS will move the 405(d) Program from the Assistant Secretary for Administration (ASA) to HHS Administration for Strategic Preparedness and Response (ASPR) Office of Critical Infrastructure Protection. The 405(d) Program is a collaborative, public-private effort between the Health Sector Coordinating Council and the federal government to align healthcare industry security practices.

Takeaways

HHS’ action to promote the National Coordinator for Health Information Technology to an Assistant Secretary provides ASTP/ONC an elevated position within the Department and formalizes its role to shape technology and data policy across HHS. Stakeholders that follow ASTP/ONC activities should view the changes as a consolidation intended to reduce redundancies and inconsistencies in HHS and to elevate the priorities of digital health policy.

To date, HHS has issued regulations and guidance on AI for specific tools, including those governing decision support interventions in health IT modules and AI-enabled medical devices, based on the agencies’ narrow authority. However, stakeholders have yet to see comprehensive guidance to regulate AI technologies. HHS’ reorganization and emergence of AI leadership may facilitate the federal government’s policy development and oversight on AI in the health sector.

Moreover, when developing and implementing policy, ONC often collaborates with other federal health agencies, including the Centers for Medicare & Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). It remains to be seen how the creation of ASTP/ONC will aid in coordinating policy activities across agencies, namely on data, privacy and security and interoperability policies, but it is surely an important goal of these organizational changes.

For more information, please contact the professionals listed below, or your regular Crowell Health Solutions contact.