HIPAA, GDPR, MDR, EHDS, Cures Act, and CMS-0057-F controls wired into sprint one for carriers, ministries, hospitals, healthcare enterprises, ISVs, and founders.
A 20-page posture brief that maps every standard to a concrete architectural decision. Not a 200-page document the engineering team will not read.
A control matrix the buyer's security team can map to their questionnaire. SOC 2, ISO 27001, HIPAA, and HITRUST columns side by side.
Compliance work sized to a 2-week sprint ticket. Audit log, RBAC, BAA, subprocessor chain shipped incrementally, not retrofitted at the launch gate.
Two-week internal dry run before the external SOC 2 Type II or ISO 27001 audit. The room is clean before the external auditor walks in.
HIPAA, GDPR, MDR, EHDS, Cures Act, CMS-0057-F, ISO/IEC 27001:2022, HITRUST, C5, HDS, Cyber Essentials Plus, covered to the version the buyer expects.
Business Associate Agreement template and a documented subprocessor list ready at the first procurement review. Not paperwork on the critical path.
Outcomes from compliance engagements across payer innovation teams, hospital IT groups, medical-device makers, and healthcare ISVs.
Compliance posture brief that maps every standard to an architectural decision.
Sprint cadence for compliance check-ins, not a 200-page document at month six.
Audit-ready posture across SOC 2 Type II, ISO 27001, HIPAA, and MDR engagements.
Compliance posture is a build constraint from sprint one, not a launch gate at month six. The retrofit panic does not happen.
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One document, under 20 pages, that maps every applicable standard to a concrete architectural decision. HIPAA Security Rule controls mapped to the audit-log table and the access-control layer. GDPR Article 32 mapped to encryption at rest and the subprocessor chain. CMS-0057-F mapped to the payer-to-payer FHIR API. The buyer's security team can map it to their questionnaire without a translation layer.
Each sprint has one compliance ticket sized to fit. Sprint one ships the audit-log table and the role-based access control. Sprint two ships the Business Associate Agreement template and the subprocessor list. Sprint three ships the encryption-at-rest configuration and the key-rotation runbook. By the time the external SOC 2 Type II or ISO 27001 audit starts, the controls are already in production and tested.
HIPAA for US payers, providers, and Business Associates. GDPR for any EU patient data. MDR for medical-device software entering the EU. EHDS for cross-border health data exchange in the European Health Data Space. Cures Act information-blocking rules for US providers. CMS-0057-F payer-to-payer and provider FHIR APIs. SOC 2 Type II and ISO/IEC 27001:2022 for procurement. HITRUST, C5, HDS, and Cyber Essentials Plus when the buyer requires them.
A two-week dry run before the external SOC 2 Type II or ISO 27001 audit kicks off. The Life Value team sits with the buyer's security lead, walks every control in the matrix, pulls the actual audit-log evidence, tests the access-control matrix against the role table, and confirms the Business Associate Agreement and subprocessor chain are signed and current. The external auditor sees a clean room, not a scramble.
Whether you're launching a new solution or scaling an existing product, Life Value gives you the clarity, speed, and compliance needed to move with confidence.
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