A 2-week diagnostic for payers, ministries, hospitals, medical-device makers, ISVs, and founders. EU AI Act conformity, HIPAA data lineage, FDA SaMD class, GDPR Article 22.
EU AI Act risk class, FDA SaMD class, and GDPR Article 22 exposure documented before a single line of model code is shipped.
Every PHI source, subprocessor, and Business Associate Agreement in the inference path mapped and gap-checked against HHS OCR guidance.
Data quality, model governance, regulatory class, security posture, clinician workflow, and operational monitoring graded on the same rubric.
Clinical, data, and security or privacy leads in the room together. The score reflects how the AI will run, not how it is described in a deck.
Ranked fixes with an owner, an evidence artifact, and a date. Sized to ship inside an existing ISV, hospital, or payer team.
The report maps to the security questionnaire a carrier, ministry, or health system will send. SOC 2 and ISO 27001 evidence pointers included.
What payers, hospitals, medical-device makers, ISVs, and founders do with the score after the workshop closes.
From workshop kickoff to scored report and 90-day remediation roadmap.
Data lineage, model governance, regulatory class, security, workflow, monitoring.
EU AI Act, HIPAA, FDA SaMD, HHS OCR guidance, GDPR Article 22 scored together.
A healthcare-specific rubric, scored against named regulations, delivered as a remediation plan a real team can execute in 90 days.
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By intended purpose, not by model type. A clinical decision support tool that influences diagnosis or treatment is high-risk under Annex III. A patient-facing chatbot that triages symptoms is high-risk if the output drives clinical action, limited-risk if it only routes calls. We document the classification, the Annex reference, and the conformity assessment route. A payer scoring fraud signals lands differently from a hospital running ambient scribe. The classification drives the entire compliance plan.
As two separate questions on the same dataset. HIPAA controls the data lineage: what PHI enters the training set, which Business Associate Agreement covers each subprocessor, how audit logs prove access. FDA SaMD class controls the product itself: Class I, II, or III based on healthcare situation and significance of information. A radiology triage model is Class II or III. A wellness tracker is unregulated. The readiness report scores both axes independently because they pass or fail on different evidence.
Three roles, two weeks, one room when possible. A clinical lead who can describe how the AI output enters the care pathway. A data lead who can walk the lineage from EHR or claims source to model input. A security or privacy lead who owns the Business Associate Agreement, GDPR Article 22 disclosures, and audit trail. For a payer that is innovation plus actuarial plus legal. For a hospital that is CMIO plus CTO plus DPO. Without those three the scoring is guesswork.
Ranked fixes tied to the six scored dimensions, each with an owner, an evidence artifact, and a date. Examples: sign the missing Business Associate Agreement with the inference subprocessor. Wire model audit logs into the existing SIEM. Add a GDPR Article 22 human-review path for any automated denial. File the FDA SaMD pre-submission. Publish the EU AI Act technical documentation under Article 11. The roadmap is sized so a hospital, payer, or ISV can execute it without doubling headcount.
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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