{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"Global Perspectives on Digital Health","title":"Regulatory strategy for founders and policy makers","html":"","width":"100%","height":180,"duration":3308,"description":"Practical breadth and depth on the global state of regulation from someone at the cutting edge of regulatory policy. Shubs welcomes Hugh Harvey, founder of Hardian Health and a regulatory expert in digital health. Shubs and Hugh discuss the complex landscape of medical device regulation worldwide, with emphasis on how these frameworks impact digital health innovation in low and middle-income countries (LMICs). Guest BackgroundHugh Harvey is a former radiologist who transitioned to the digital health industry. After working at Babylon Health and serving as Clinical Director at Kheiron Medical (where they secured Europe's first CE mark for a deep learning-based breast cancer detection device), Hugh founded Hardian Health to help companies navigate regulatory pathways for AI and digital health solutions.Key Discussion PointsThe Global State of Medical Device RegulationRegulatory Variation: Hugh explains the significant differences in regulatory approaches between regions like the EU (stricter) and the US (increasingly deregulatory)(Some) LMIC Contexts: Only about 40% of African countries have actual medical device regulations, with only South Africa having comprehensive frameworksCybersecurity Risks: Medical health data sells for more than financial data on black markets, making robust regulation essential for protecting patientsChallenges for Digital Health InnovatorsFounder Misconceptions: Many startups allocate insufficient resources for regulatory compliance. Regulatory compliance should represent 5-10% of a company's overall budget.Regulatory Debt: Postponing regulatory considerations creates compounding challenges that become increasingly difficult to address later down the lineLarge Language Models: Hugh's skepticism about LLMs in healthcare, noting they're \"massively overrated\" for medical reasoning tasks and face significant regulatory hurdles, and yet Hugh sees some promise over the hill. Practical Guidance for Digital Health CompaniesGetting the mindset...","thumbnail_url":"https://img.transistorcdn.com/hZPIZ-J0wiJx5Bagp4XUMpa5ahoYyL_sqq9C89IZlTc/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS85ODYz/N2YyYzVkYzhjMjY2/YWQyMjc4YmU3MWM0/YWE2NS5qcGc.webp","thumbnail_width":300,"thumbnail_height":300}