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Most hospitals will not wake up one Monday on pure FHIR. They run decades of HL7 version 2 feeds for ADT, orders, and results, while new programmes demand FHIR APIs for apps, national exchanges, and analytics. The winning strategy is coexistence with clear contracts — not a big-…
In many hospitals the network is not a utility you assume; it is a weather pattern. Clinics lose the uplink during storms, shared microwave links saturate at noon, and power events take the data centre offline while wards keep treating patients. Offline-first design is how custo…
A SaMD release is not finished when the build is green. Under the EU Medical Device Regulation, a software update is either a controlled change with evidence or an uncontrolled drift of the device on the market. Teams that treat patches as “just IT” discover the gap when a notif…
When a hospital auditor asks who changed a medication order, when they changed it, and why, the answer cannot be a reconstructed story from chat logs. Custom healthcare software either produces an immutable audit trail or it produces theatre. The difference shows up the moment s…
Connecting each analyser or medical device straight to the clinical system feels fastest on the first interface. By the tenth, every firmware upgrade is a mini-project, mappings drift, and nobody can say which message produced a wrong result. Middleware versus point-to-point is …
Not every clinical algorithm is a medical device, and not every “AI feature” in a health app is harmless productivity software. The line is intended use: what the software claims for diagnosis, treatment, prevention, or clinical decisions, and how far users are expected to rely …
Calling an interface “FHIR” does not make it interoperable. FHIR becomes valuable when it is treated as a deployable contract: agreed profiles, identity rules, terminology bindings, and acknowledgement behaviour that both sides can test before go-live. Without that contract, you…
Build versus buy in healthcare is rarely binary. The real question is which parts of the stack you will own for a decade: roadmap, integrations, regulatory evidence, and the cost of changing course when policy or care models move. Packaged platforms look cheaper on day one. Cust…
IEC 62304 still tells medical device software teams how to classify safety, control SOUP, and govern change. Early 2026 raised the stakes: FDA’s Quality Management System Regulation (QMSR) is live, and eSTAR filings expect a software story that maps cleanly to design control and…
