What kind of healthcare product are you shipping?
Eight product types, each with the integrations and protocols it runs on. What breaks in an EHR is not what breaks in an infusion pump, and the standards that reach the two are different. Start from the product and the applicable standards, services and situations follow from it.
What are you shipping?
Medical billing
What breaks in medical billing software, why the defects pass every schema check, and which published artefact a claim has to be tested against.
HL7 v2, FHIR R4, ASC X12N 005010, ICD-10-CM, ICD-10-PCS
EHR and EMR
What breaks in an electronic health record under test, which certification and privacy rules a record system answers to, and where the interface and migration defects concentrate.
HL7 v2, FHIR R4, ICD-10
IoMT and connected devices
Why a connected medical device is tested against a network its manufacturer does not own, and why a vulnerability in a third party component becomes a design question instead of a ticket.
HL7 v2, DICOM, FHIR R4
Patient portals
What breaks in a patient portal driven by an untrained user, why HIPAA leaves proxy eligibility to state law, and what a suite has to cover on the identity, delegation and patient rights paths.
FHIR R4, HL7 v2
Clinical trials
What breaks in EDC and randomisation systems, why the trial record has to stay readable after the software is switched off, and why a test that reveals a treatment assignment is a defect.
FHIR R4, DICOM, HL7 v2
Remote patient monitoring
What breaks when readings arrive continuously from outside the clinic: gaps, duplicates, readings out of order, clocks that disagree, and what the system does while nothing arrives.
HL7 v2, FHIR R4
SaMD
Why SaMD test records sit inside the regulatory file, which classification decides how much testing binds, and what an assessor opens first when the software is the device.
Telemedicine
What breaks in a telemedicine platform once the call leaves the office network, which standards reach it, and how the encounter record is checked after the consultation ends.
HL7 v2, FHIR R4, ICD-10
What does validating your product actually involve?
Answer four questions about your markets, your product type and its integrations. You get the standards that reach you, the artefacts each one asks you to produce, and which of them a test supplier delivers.