Articles
SaMD Classification Explained: Navigating EU & UK Regulatory Requirements
Standardised FHIR Pipelines and the Hospital IT Queue
A digital health product rarely loses a year because the clinical logic is unfinished. It loses the year in a queue it does not control: a hospital interface request, an EPR supplier change note, and a safety case that still cannot name the source system. A standardised pipeline…
Bidirectional workflow between Prolab LIS and the Beckman Coulter DxI 9000
Generative AI in Clinical Workflows: Governance Gates
Generative models draft discharge summaries, suggest codes, and rewrite patient instructions in seconds. Speed is not the hard part. The hard part is stopping unverified text from becoming clinical truth. Draft, review, and release gates turn generative AI from a silent risk int…
Yoctobe Health Suite 5.1.0 — audit log across every module
Version 5.1.0 of Yoctobe Health Suite extends audit log coverage to every module — EHR, LIS, Pharmacy, Imaging, Scheduling, and ERP. Change history is now readable at a glance, consistent throughout the platform, and immutable by design.
Multi-Facility HIS Without Siloed Charts
Multi-facility hospital groups still lose patients between sites: not in ambulances, but in charts. Different medical record numbers, duplicated allergies, and encounters that cannot travel turn “one organisation” into several incompatible histories. The fix is not a bigger arch…
Cybersecurity for Connected SaMD on Hospital Networks
Connected SaMD earns its clinical value on the hospital network, and inherits that network’s threat model. Segmentation, software bills of materials, and realistic patch windows are not IT niceties. They are how you keep a regulated software function safe without freezing care w…
Healthcare Data Residency and Sovereignty by Design
Data residency conversations in healthcare still start too late: usually after a cloud region is chosen or a vendor contract is signed. Sovereignty is not a checkbox on a procurement form. It is an integration architecture problem: where data may live, who may process it, and wh…
Clinical Decision Support: Logging, Override, and Liability
Clinical decision support and AI assist tools rarely fail in dramatic ways. They fail in the quiet gap between a suggestion on screen and a decision in the record. When that gap is not logged, override trails evaporate, and liability debates become speculation rather than eviden…
Usability Engineering for SaMD (IEC 62366)
For Software as a Medical Device, a confusing screen is not a UX debt item — it is a hazard. IEC 62366 frames usability engineering as a systematic way to find use errors, reduce them through design, and produce evidence that intended users can operate the software safely. Teams…
HL7 v2 and FHIR Coexistence in Hospital Integration
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-…







