Authorities
Also known as: Regulatory Bodies, Payors, Specialty Societies, Governing Bodies
H-BMC Block 5 — regulatory bodies, payors, specialty boards, and other institutional forces that shape market access.
Full Definition
Authorities are the institutional actors that establish the rules within which a healthcare solution must operate. They include the FDA (regulatory clearance), CMS and private payors (reimbursement), specialty societies (clinical guidelines), and hospital credentialing bodies (privileging). Understanding authorities means knowing which approvals are required, what evidence standards apply, what the timeline looks like, and how authority decisions affect commercial strategy.
Example
A digital therapeutics company achieves FDA clearance but discovers that CMS has not established a reimbursement code for its category. Without a reimbursement pathway, economic buyers have no mechanism to pay for it regardless of clinical value.