HIPAA compliance for healthtech and digital health teams
HIPAA applies to covered entities and to the business associates that handle protected health information on their behalf, which includes many software vendors. The Security Rule sets expectations for protecting electronic protected health information (ePHI).
The three safeguard families
The Security Rule organizes requirements into administrative, physical and technical safeguards. Some specifications are required and others are addressable, meaning you must implement them or document an equivalent alternative.
- Administrative: risk analysis, workforce training, access management, incident procedures
- Physical: facility access and device and media controls
- Technical: access control, audit controls, integrity protection, transmission security
Business associate agreements
If you process ePHI for a covered entity you need a business associate agreement with them, and with any subcontractors who touch that data in turn.
Breach notification
The Breach Notification Rule requires notifying affected individuals without unreasonable delay and no later than 60 days after discovery. Larger breaches also trigger notice to regulators and, in some cases, the media.
Technical evidence that matters
- Unique user identification and multi-factor access to systems holding ePHI
- Encryption at rest and in transit
- Audit logs that are retained and reviewed
- Timely removal of access when people leave
- A documented, current risk analysis
How Cevro helps
- Cevro runs automated checks against 11 connected systems (cloud, source code, identity, people and payments) and maps each result to HIPAA and the other frameworks you track.
- Every failing control comes with a specific fix and a way to re-check it, so the gap list turns into a task list.
- Evidence collected for one framework is reused for the others, and anything a scan can't produce goes into the evidence vault.
- A live trust page and exportable evidence let you answer buyers and auditors without starting from a blank spreadsheet.
Frequently asked questions
Is there a HIPAA certification?
No official HIPAA certification exists. Compliance is demonstrated through your risk analysis, safeguards, documentation and, often, third-party assessments.
Does HIPAA apply outside the United States?
It applies based on whether you handle protected health information for US covered entities, not on where you are based. Non-US vendors serving US healthcare customers are often in scope.