Privacy frameworks designed for the complexity of health data and clinical innovation
Formiti provides outsourced DPO support, industrialised DPIA delivery, and AI governance for life sciences organisations, clinical research companies, and HealthTech platforms operating across regulated markets.
What we cover in this sector
- Sector-specialist outsourced DPO support
- Industrialised DPIA factory for clinical trials
- AI governance for medical devices and digital health
- NHS DSPT alignment and UK health data compliance
- Cross-border clinical data transfer frameworks
- Vendor oversight for CROs and health platforms
Why health data demands a specialist privacy approach
Life sciences and HealthTech organisations handle some of the most sensitive personal data in any industry. The combination of special category health data, global clinical operations, and emerging AI-driven diagnostics creates a compliance environment where generic programmes consistently fall short.
Sensitive data at the core
Health data is special category data under GDPR. Every processing activity — from clinical trial consent to patient app analytics — requires a higher legal basis, stronger safeguards, and more rigorous impact assessment.
Multi-regulator complexity
Life sciences companies answer to data protection authorities, health regulators, ethics committees, and research governance bodies simultaneously. Compliance must satisfy overlapping frameworks without creating operational paralysis.
Innovation under scrutiny
AI-powered diagnostics, real-world evidence platforms, and digital therapeutics are transforming healthcare — but each innovation brings new governance obligations under both privacy law and the EU AI Act.
Sector Challenges
The privacy and governance challenges facing life sciences
Life sciences organisations face compliance pressures that few other sectors encounter.
Clinical trial data governance
Multi-site, multi-country clinical trials generate complex data flows requiring coordinated consent, purpose limitation, and transfer mechanisms across jurisdictions.
AI in diagnostics and drug discovery
Machine learning models trained on patient data face heightened scrutiny under GDPR and the EU AI Act, requiring algorithmic impact assessments and transparency documentation.
Real-world evidence and secondary use
Using existing health data for research, analytics, or commercial purposes demands careful legal basis analysis, anonymisation validation, and ethics review.
Vendor and CRO oversight
Contract research organisations, laboratory services, and digital health vendors process sensitive data on behalf of sponsors — each requiring structured DPA and sub-processor management.
International health data transfers
Clinical data frequently moves across borders. Transfer impact assessments, supplementary measures, and local representation requirements apply differently in each market.
Patient rights and transparency
Data subjects in clinical and healthcare settings have heightened rights expectations. Managing consent withdrawal, access requests, and data portability requires operational readiness.
How We Help
How Formiti supports life sciences and HealthTech
Formiti delivers privacy and AI governance through a model built specifically for the operational realities of health data.
Outsourced DPO with health sector expertise
A named DPO backed by specialists who understand clinical trial governance, health data regulation, and the interplay between GDPR and sector-specific frameworks.
Industrialised DPIA factory
Reusable, sector-adapted DPIA templates and delivery processes that reduce assessment time and cost across multi-site clinical programmes.
AI governance for medical devices and digital health
End-to-end AI governance covering EU AI Act classification, algorithmic impact assessments, MDR alignment, and clinical decision support system accountability.
Cross-border clinical data frameworks
Practical transfer mechanisms for international clinical trials, including SCCs, TIAs, and jurisdiction-specific supplementary measures.
Vendor and CRO due diligence
Structured vendor assessment programmes covering data processing agreements, sub-processor oversight, and ongoing risk monitoring for the clinical supply chain.
NHS and UK health compliance
NHS DSPT alignment, Caldicott Principle support, and UK-specific health data compliance for organisations operating in the NHS ecosystem.
Related Services
Relevant service pathways
Connect this sector expertise with Formiti's core consulting services.
Life Sciences DPO–DPIA Factory & AI Governance
Our dedicated three-pillar service for life sciences
Outsourced Data Protection Officer
Embedded DPO support with health sector expertise
AI & Vendor Risk Management
AI governance and vendor oversight frameworks
Birmingham HealthTech Programme
Regional programme for West Midlands health innovation
Our Approach
The DPIA Factory model
Traditional DPIA delivery in life sciences is slow, expensive, and difficult to scale across multi-site studies. Formiti's DPIA Factory industrialises the process without compromising quality.
Reusable templates
Sector-specific DPIA templates that can be adapted across study types, reducing time-to-completion from weeks to days.
Consistent quality
Standardised methodology ensures every assessment meets regulatory expectations across jurisdictions and supervisory authorities.
Scalable delivery
Built to handle volume — whether you are running one study or fifty, the framework scales without proportional cost increase.
Frequently Asked Questions
Common questions about Formiti's life sciences & healthtech privacy and AI governance services.
Do you have direct experience in life sciences privacy?
Yes. Formiti supports life sciences organisations including clinical research sponsors, CROs, and HealthTech platforms with outsourced DPO, DPIA delivery, and AI governance services.
How does the DPIA Factory reduce costs?
By using reusable, sector-adapted templates and standardised processes, we reduce the time and cost of each assessment while maintaining the quality regulators expect.
Can you support AI governance for medical devices?
Yes. We deliver AI governance frameworks covering EU AI Act classification, MDR alignment, algorithmic impact assessments, and ongoing monitoring for AI-enabled medical devices.
Do you handle international clinical data transfers?
Absolutely. We provide practical transfer frameworks including SCCs, transfer impact assessments, and jurisdiction-specific supplementary measures for multi-country clinical programmes.
How does the outsourced DPO service work for clinical research?
We provide a named DPO backed by a team that understands clinical trial governance, ethics review processes, and health data regulation — not just generic GDPR compliance.
Discuss privacy and AI governance for your health data programme
From clinical trial compliance to AI-powered diagnostics, Formiti's life sciences team delivers the privacy frameworks, impact assessments, and governance support your organisation needs.
What happens next
We discuss your sector-specific compliance requirements.
We schedule a consultation to assess scope, risk, and priorities.
If aligned, we deliver a tailored proposal within days.