TOPIC
Compliance
11 entries across the knowledge base
SaMD & regulation (FDA · CDSCO · CE)When does your software become a medical device? The question decides whether you ship on Friday or spend two years in a regulatory pathway — and the line is narrower than most teams assume.article · 8 min · practitionerMedical ethicsThe four principles every clinician learns, applied to the systems we build — because a design decision is an ethical decision that nobody labelled as one.article · 8 min · foundationHITRUST · ISO 27001Certifications that prove you have a security management system. What they actually attest to, what they don't, and why a certificate is a floor rather than a finish line.article · 7 min · practitionerHIPAA essentialsThe US baseline for protecting health information: who it covers, the Privacy and Security Rules, and what 'minimum necessary' and breach notification actually require.article · 5 min · foundationGDPREurope's data protection regulation, and why it matters to people who will never work in Europe: it set the template most of the world copied — including the parts India deliberately didn't.article · 8 min · practitionerIndia's DPDP ActIndia's Digital Personal Data Protection Act 2023 — consent, the data fiduciary's duties, and what it means for health data and ABDM.article · 5 min · foundationDe-identification of health dataTurning patient data into data you can safely analyse or share — Safe Harbor vs Expert Determination, and why 'anonymous' is harder than deleting the name.article · 5 min · foundationConsent managementConsent is not a signature you collect once. It is a scoped, revocable, time-bound object the system must enforce — and most health systems treat it as a form, which is why it fails.article · 8 min · practitionerAI ethics & governance in healthWhat it takes to deploy clinical AI responsibly — bias, transparency, human oversight, and the regulatory frame (FDA, EU AI Act) now forming around it.article · 6 min · foundation