Richard Frank, Md, Phd Email and Phone Number

Me - asset-based resilience in a "1st generation" graduateMy 35 years’ global success in a) regulatory labeling of, b) public and private coverage and payment for, and c) clinical adoption of therapeutic and diagnostic drugs and devices - now including AI - can be attributed to a diverse and growing skillset, domain knowledge, and network ranging from translational medicine to data science. Long experience has facilitated opinion leadership in clinical evidentiary standards and related matters of government policy. My passions include addressing product-, market-, or delivery system-specific inefficiencies and issues which burden payers and delay or skew patients’ access to the benefits of innovation. I am devoted to the development of and advocacy for policy, regulations, standards, best practices, and reimbursement in healthcare AI. My most recent success in this regard was publication of the Taxonomy for AI as an appendix to the CPT Code Set.• Expert testimony to agencies and legislators regarding innovation• Leadership of product teams in development of coverage and adoption strategy • Persuasive engagement of peers in regulators, payers, professional societies, & patient advocateso FDA pre-subs and review committees for product approvals and clearanceso CMS MEDCAC, AHRQ, NIST, USPSTF, Private payers’ coverage committeeso Professional societies re; development of Clinical Practice Guidelineso ACS, GO2 Alliance, AHA, et al for coverage and adoption strategies• Presentation of evidence to key influencers and decision-makers (eg Ministers of Health)• Design and conduct of clinical trials programs from phase I to post-market registries• Development and leadership of industry advocacy groups including AI Committees• Development of coalitions, PPPs to grow capacity in healthcare delivery networks* Develop best practices with the AMA, FDA, CMS, and ABAIM for AI in healthcareI am particularly adept at persuasive deployment of clinical and economic evidence to decision-makers and key influencers, credibly asserting the safety, efficacy, reasonableness, necessity, and economic benefits of the product or service. Persuasive deployment of evidence is the basis for my success in reforming national barriers to labeling, coverage, and adoption, resulting in broadening of patient access and growth in market size. My "next big thing" is to enable appropriate valuation, coverage, and payment for "the work done by machines", ie AI.