ISO 27001 for healthtech
PHI changes the scoping math — and ISO 27701 turns the ISMS into a privacy story your customers' legal teams understand.
Why healthtech certifies
Healthcare customers and partners want evidence that patient data is protected by a real management system, not just policies. ISO 27001 is the internationally recognized answer; paired with ISO 27701 (privacy information management), it speaks directly to data-protection officers.
Scoping with PHI in mind
- Scope the PHI-handling systems explicitly. Ambiguous scope around health data is the first thing auditors and customers probe.
- Consider ISO 27701. The privacy extension adds audit days (roughly +15% in our estimator) but answers the privacy questions health systems always ask.
- US companies: coordinate with HIPAA and SOC 2. The control overlap is large — one evidence set can serve ISO 27001, a HIPAA risk analysis, and SOC 2.
CB selection for healthtech
Look for CBs with healthcare-adjacent experience and ISO 27701 in scope. Several CBs in our directory (BARR Advisory, Schellman, Prescient) list ISO 27701 and healthcare-relevant frameworks together.
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