Colin Rom

Managing Director, Science and Innovation Policy, Mayo Clinic

Speaker

Former Sr. Advisor to the FDA Commissioner

Colin Rom is currently Managing Director of Science and Innovation Policy at Mayo Clinic. The portfolio includes issues related to regulatory and policy landscapes facing Mayo Clinic Labs, Ventures, Platform, , Research and Mayo Clinic’s Cancer Center. Prior to Mayo, Colin served as the Senior Advisor to Commissioner Stephen Hahn at the U.S. Food & Drug Administration and also spent a year in FDA’s office of policy managing agency-wide initiatives around drug pricing, innovation and advanced manufacturing. Before FDA, Colin worked for a year at the White House Office of Management and Budget helping to manage, develop and negotiate the federal healthcare budget and spent five years in the U.S. Senate including two years on the Senate HELP Committee working on life sciences policy.

Topic

12:30 PM - 1:15 PM

Thursday August 25, 2022

Regulatory Landscape Facing Telehealth Innovation and Coverage

  • An overview of Mayo Clinic investment and patient/provider experience in Acute Care at Home model and digital/remote health
  • Leveraging remote monitoring and Software as medical device (SaMD) products
  • Understanding the regulatory process for SaMD at FDA and next steps
  • A look at the future of telehealth policy at HHS and CMS reimbursement on telehealth, focusing on how the PHE impacts telehealth coverage and reimbursement
  • How CMS views consumerization as they make decisions on reimbursement for RPM and RTM technologies
  • How leaders within HHS/CMS view the continual shift from FFS to VBC
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