By: Marc Goldsand, Partner and Co-Founder  Goldsand Fridberg, LLP I am 46 years old. I am a Florida-board certified health attorney and specialize in digital and related technologies. I have access to a lot of cutting-edge health care companies and products.  About three years ago, I had my own version of a mid-life crisis, an episode no doubt prompted by my exposure to the offerings of some of my cutting-edge clients. My version of a mid-life crisis? I fell hard for the long

Introduction Utah has positioned itself at the forefront of state-level artificial intelligence governance through enactment and implementation of the Utah Artificial Intelligence Policy Act (the “AI Policy Act”).  The statute establishes an AI Learning Laboratory and authorizes temporary regulatory mitigation agreements that allow the deployment of AI technologies under reduced regulatory constraint in a program generally referred to as an “AI Sandbox.”   Utah is not alone i

AI can save your holiday season or completely destroy it, depending how you use it… As busy professionals juggling year-end deadlines and holiday parties, how can we survive the season without losing our minds? Enter the AI assistant: Your new digital elf with a potentially problematic relationship with confidentiality. AI assistants promise salvation during the holiday season: draft contracts while buying gifts, summarize documents during cookie exchanges, organize your cale

Not to bury the lede, the answer is yes. States were doing so before the current federal deregulation, and I believe this trend will pick up pace now. To be clear, there are certain subject areas in health care that the states have historically regulated. For example, state medical and professional licensure boards oversee the delivery of licensed health care services. The authority of these state agencies sometimes overlaps with federal agencies regulating in adjacent areas,

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 organizat

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. When insurance pays, the best companies don't always win—if by "best" we mean the most satisfying, helpful, and econ

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. Below are our key takeaways from the law. The MHMD authorizes a private right of action where a plaintiff can recover attorneys' fees and treble damages. Most data privacy laws can on

While my work in the digital health sector is extremely dynamic and rewarding, there can be a Groundhog’s Day aspect to it as well.  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.  Below are 10 observations and suggestions based on my own experiences over 12+ years in digital health.  Payor contracting and credentialing is

Health and digital health businesses using web tracking tools such as pixels, beacons, and cookies may be violating health laws by sharing regulated health information with advertisers. 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. Until now, regulators