Robert Botkin, Marci Norton, Tim St. Clair, Olivia Osburn, and Caroline McCracken co-authored an article in MedCityNews about a recurring product-design conflict facing medical device companies and digital health founders that are developing and deploying healthcare artificial intelligence (AI) tools. Their article focused on three legal regimes pulling in different directions: patent strategy, FDA reality, and HIPAA constraints. 

"The strongest business case is usually an improving model, one that learns from new clinical data over time," they wrote. "However, a 'locked' or 'fixed' model that does not automatically learn or adapt after deployment may raise fewer regulatory concerns than one that continuously changes based on new data. And the data architecture needed to bridge that gap runs directly into considerations over federal laws restricting release of medical information."

"Three legal regimes — patent strategy, U.S. Food and Drug Administration regulation, and HIPAA-driven patient privacy obligations — are pulling in different directions, and the developers that navigate them well will be the ones that plan for all three from the start," they continued. 

Click here to read the full article: The AI Tension in Healthcare: Patent Strategy, FDA Reality, and HIPAA Constraints

MedCityNews is a leading trade outlet focused on the business of healthcare innovation.