Healthcare Technology Consultants
Healthcare technology experts who understand clinical workflows, patient data regulations, and the integration challenges of a fragmented health IT landscape.
Healthcare technology is one of the most complex sectors: patient safety requirements, strict data regulations (HIPAA, GDPR for health data), legacy hospital systems, and clinical workflow constraints make every project uniquely challenging. Consultants who have worked inside health systems or with digital health companies bring irreplaceable domain knowledge.
Key industry challenges
Key challenges include integrating with existing EHR systems via HL7 or FHIR standards, achieving HIPAA and healthcare GDPR compliance, navigating medical device regulations if software qualifies as a medical device, and designing for clinical users who prioritise safety over convenience.
Expertise by area
Data & Compliance
AI & Analytics in Health
Frequently asked questions
When does health software become a regulated medical device?
Software qualifies as a medical device (and must meet MDR in the EU or FDA regulations in the US) when it is intended to diagnose, prevent, monitor, treat, or alleviate a disease or condition. Administrative health software, wellness apps, and clinical decision support tools that don't drive specific clinical decisions are generally exempt. A consultant with regulatory experience can assess your specific product.
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