With both the widespread focus and rapid adoption of AI tools, many digital health organizations are feeling pressure—from both internal and external stakeholders and business arrangements—to formalize the organization’s approach to AI (e.g., preparing a formal policy/procedure on use of AI). Larger organizations are now often incorporating in every business arrangement an AI addendum or similar terms that attempt to force business partners into complying with the organization’s approach to use of AI. 

Very few healthcare startups succeed without taking insurance. Consumers expect insurance to pay for healthcare and tend to resist paying for digital health services on their own. As a result, most companies eventually surrender to the hard realities of taking insurance sooner or later, with its perverse incentives, onerous requirements, and seeming unfairness.

No matter the company, the innovation, or the level of funding, nearly every emerging start-up that provides services to patients experiences similar growing pains, and many also make the same mistakes.  Here are 10 observations and suggestions based on my own experiences over 12+ years in digital health. 

Washington passed a health privacy law called the My Health My Data Act (MHMD) in 2023 that is going into effect on March 31, 2024. This law is significant in several respects and we recommend that organizations with operations in Washington take certain actions to ensure they are in compliance.

On December 1, 2022, the U.S. Department of Health and Human Services' (HHS) Office of Civil Rights (OCR) issued a bulletin (the “Bulletin”) warning that HIPAA covered entities’ and business associates’ (“regulated entities”) use of tracking technology may violate HIPAA.