Navigating the Regulatory Alphabet Soup
While **HIPAA** is the big one, US healthcare software must navigate a complex web of other regulations. Missing these can stall a product launch or lead to lawsuits.
1. HITECH Act
Updates HIPAA with stricter enforcement and breach notification rules. It mandates that business associates (vendors) are directly liable for compliance.
2. 21 CFR Part 11 (FDA)
For software used in clinical trials or medical device manufacturing, this regulation governs electronic signatures and records. It ensures that digital records are as legally valid as paper signatures.
3. CCPA / CPRA
If you serve patients in California, the California Consumer Privacy Act gives them rights over their data similar to GDPR. This includes the right to know what data is collected and the right to delete it.
4. SOC 2 Type II
While not a law, big US hospital systems will not buy software that isn’t SOC 2 certified. It’s a third-party audit that verifies your security, availability, and confidentiality controls.
Summary
Compliance isn’t a checkbox; it’s a culture. Building your software with a ‘Compliance by Design’ framework saves expensive re-engineering later.
