During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of the COVID-19 public health emergency (PHE).

Session panelists:

• Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health, Inc.
• Latoya S. Thomas, Head of Policy and Government Affairs, Included Health
• Kate Tipping, Deputy Director, Regulatory and Policy Affairs Division Office of the National Coordinator for Health Information Technology (ONC)
• Moderators:
  • Kristen O’Brien, Vice President, McDermott+Consulting
  • Rachel Stauffer, Senior Director, McDermott+Consulting

IN DEPTH

Top takeaways included:

1. As the landscape changes, multiple regulatory entities continue to look closely at digital health, especially telemedicine and AI. Agencies are contemplating how to regulate effectively while focusing on the advancement of health equity and social determinants of health.
2. ONC is proposing additional transparency requirements for AI in Certified Health IT through its recently proposed rule Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1). Through these new proposed transparency requirements, ONC is focused on promoting trust and increasing adoption by providers of AI tools embedded within Certified Health IT products. However, given that certain uses of AI in healthcare are already regulated by the US Food & Drug Administration, these new proposals may add additional regulatory layers to AI outside of current authorities.
3. The end of PHE flexibilities is causing frustration and increased costs of compliance among digital-health providers. For example, the expiration of eased restrictions regarding the cross-border practice of medicine and other scope-of-practice limitations is requiring digital-health platforms to confirm that providers are appropriately licensed in applicable states and that care teams comprise providers practicing within the scope of their license.
4. Industry stakeholders would like to see the US Centers for Medicare and Medicaid Services (CMS) take action on reimbursement for asynchronous telehealth services, primarily because the historical paradigm of reimbursing for synchronous telehealth services provided by a distant site to an originating site no longer reflects effective telehealth modalities in use today.