Healthcare is the most heavily regulated large industry in the US economy. A product that would be a simple app in another sector can be a medical device, a covered entity's business associate, a federal health care program referral source and the unlicensed practice of medicine, all at once. This section maps the rules that decide what a healthcare company may sell, how it may be paid, whom it may pay, what it may do with data and who may deliver care: the FDA, HIPAA and the FTC, the fraud-and-abuse trio (Stark, the Anti-Kickback Statute and the False Claims Act), the corporate practice of medicine, licensure and controlled-substance prescribing, and the state laws layered on top. It ends with the international rules (GDPR, EU MDR and AI Act, India, and African data-protection law) that matter for the global and West African thread of this knowledge base.
What the study covers
- 1Overview: five questions every healthcare company must answer
- 2FDA: getting a product onto the market
- 3HIPAA and health data privacy
- 4Fraud and abuse: Stark, the Anti-Kickback Statute and the False Claims Act
- 5Who may practise, and who may own: CPOM, licensure and prescribing
- 6Other federal and state rules that matter commercially
- 7Outside the US: the rules that matter for global and African companies
- 8Landmark companies and cases
- 9Key numbers
- 10Pitfalls
- 11How an expert thinks about it
- 12Related sections