Artificial Intelligence and Future Technologies
Advanced technology development offers immense benefits to the telehealth and broader healthcare marketplace, but challenges to its safe and secure application exist. Navigating the regulatory and policy landscape is an ongoing challenge as we work to understand emerging capabilities and their impact on the delivery of care. CTeL is tracking the development of AI-focused legislation, coalitions, polices, and more.
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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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As AI’s capabilities grow, so do its implications for Americans’ safety and security. With this Executive Order, the President directs the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.
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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.
AI and Future Technology Resources
Trustworthy AI Playbook: Guidance on major trustworthy Artificial Intelligence concepts and how to use AI solutions safely and confidently.
HHS Artificial Intelligence Strategy: Intended to encourage AI adoption; enable HHS-wide familiarity, comfort, and fluency with artificial intelligence (AI) technology and its potential; promote AI scaling with the application of best practices and lessons learned from piloting and implementing AI capabilities to additional domains and use cases across HHS; and spark AI acceleration by increasing the speed at which HHS adopts and scales AI and ML.
Artificial Intelligence Use Cases Inventory: Executive Order 13960, “Promoting the Use of Trustworthy Artificial Intelligence in the Federal Government,” requires agencies to prepare an inventory of non-classified and non-sensitive current and planned Artificial Intelligence (AI) use cases.
Artificial Intelligence at HHS: Statues and Authorities: Links to relevant documents like executive orders, laws, and regulations.
CMS AI Resources: Those who wish to engage in AI-related activities, as either a CMS employee, partner, or vendor, should be aware of federal policies regarding the application of AI. Includes links to foundational governance documents on AI and other related resources.
FDA Digital Health and Artificial Intelligence Glossary: A compilation of commonly used terms in the digital health, artificial intelligence, and machine learning space and their definitions. These definitions are either directly from, or adapted from, various public sources, including consensus standard organizations and published literature.
March 12, 2025 | 12:00 to 5:00 PM ET
Washington, D.C.
The use of Artificial Intelligence and Machine Learning (AI/ML) is growing rapidly in healthcare applications. In response, CTeL has established the AI Blue Ribbon Collaborative (AIBRC). This collaboration brings together legal, clinical, and scientific experts to provide unbiased, vendor-neutral information to drive the adoption of safe, effective AI and ML practices.
To boost the visibility of the Collaborative’s work, CTeL is hosting an AI Digital Health Tech Showcase at the U.S. Capitol on March 12, 2025, at the start of a new Congress. This event will unite subject-matter experts to demonstrate the capabilities of these emerging technologies while highlighting the importance of clear policies and regulations. CTeL’s vision is to bring together front-line clinicians and vendors in digital health to highlight how the use of these technologies directly impacts policy makers and their constituents.