Boston digital health insurance - digital therapeutics, SaMD, and virtual care.

Because the software is the product. A traditional products liability policy is built for a manufactured physical object, but a digital health company creates and transfers risk through code and data. Cyber liability responds to the data-breach and privacy exposure on the protected health information the company holds, and technology errors-and-omissions (Tech E&O) responds to failures in the performance, accuracy, or availability of the software itself. Together they are the primary product-liability vehicles, and a program that relies on traditional products liability alone is structurally inadequate for how these companies actually operate.

When a Boston digital health company handles protected health information on behalf of a hospital or health system, it is a HIPAA business associate. The business-associate agreement flows breach-notification duties, indemnity, and minimum-insurance obligations directly onto the company, and it typically dictates minimum cyber and Tech E&O limits and a required security posture. Because many Boston digital health companies partner directly with the region's hospitals and health systems, business-associate scope attaches to essentially every provider relationship and sits at the center of the program rather than at its edge.

Software is treated as software-as-a-medical-device when it is intended to diagnose, treat, cure, mitigate, or prevent disease - in other words, when the software performs a medical function rather than simply supporting administration or wellness. At that threshold the software is a regulated device, and the insurance program needs SaMD-specific structure rather than a generic technology form. Digital therapeutics and clinical decision-support tools commonly cross this line, which changes both the regulatory posture and the way products, cyber, and Tech E&O coverage have to be arranged.

Massachusetts data-privacy law - M.G.L. c. 93H and 201 CMR 17.00 - imposes state-law safeguarding and breach-notification obligations above HIPAA for any company handling identifiable personal or health data on Massachusetts residents, so a Boston company's cyber policy should cover Massachusetts-law claims explicitly alongside HIPAA breach response. A SOC 2 or comparable security posture matters because underwriters in this class expect it as a baseline condition of coverage and health-system contracts frequently require it outright - it is effectively a precondition to placing the program, not an optional enhancement.