Artificial Intelligence and Future Technologies

The Health Information Technology Advisory Committee (HITAC) has transmitted the HITAC Annual Report for Fiscal Year 2023 to the HHS Secretary and Congress. This sixth edition of the report describes HITAC’s progress during fiscal year 2023. The annual report also describes the health care industry’s progress in advancing health IT infrastructure in several target areas: design and use of technologies that advance health equity, use of technologies that support public health, interoperability, privacy and security, and patient access to information.

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Aligned with its mission of protecting, promoting, and advancing public health, and building on the Agency’s longstanding commitment to support innovative work in the development and regulation of medical products, the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) are jointly publishing this paper to provide greater transparency regarding how FDA’s medical product Centers are collaborating to safeguard public health while fostering responsible and ethical innovation.

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Effective March 11, 2024

This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for “decision support interventions,” “patient demographics and observations,” and “electronic case reporting,” as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT.

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Key Objectives of the Congressional Digital Health Caucus:

1. Informing Policymakers: The Caucus will play a crucial role in educating policymakers about the latest developments in digital health, providing insights into the potential benefits for patients, healthcare providers, and the broader healthcare system.

2. Ensuring Accessibility for All Americans: Recognizing the importance of equitable access, the Caucus will work to ensure that digital health tools are accessible to all Americans, irrespective of socio-economic status or geographical location.

3. Promoting Collaboration: The Caucus will serve as a hub for collaboration between government agencies, private sector innovators, and healthcare professionals. By fostering partnerships, the Caucus aims to accelerate the development and adoption of digital health solutions.

4. Addressing Regulatory Challenges: Digital health innovation often outpaces existing regulatory frameworks. The Caucus will advocate for policies that strike a balance between fostering innovation and ensuring patient safety and data security.

5. Advancing Research and Development: The Caucus will work to advance research and development in the digital health space, encouraging innovation that improves patient outcomes and healthcare efficiency.