Regulated Buyer Readiness Checklist

This checklist is designed to help health tech companies assess whether their data privacy, security, and AI governance posture is ready for engagement with regulated buyers such as national health services, government agencies, large healthcare providers, or for progression through medical device and federal healthcare compliance pathways.

It reflects the types of evidence most commonly requested during procurement, assurance, and regulatory review.

1. Organisational governance & accountability

☐ Clear ownership of data protection and privacy (e.g. DPO, privacy lead, or equivalent)
☐ Defined roles and responsibilities for data protection, security, and AI governance
☐ Up-to-date privacy policies and internal data handling standards approved by leadership
☐ Regular review cycle for privacy and security governance (not one-off compliance)

2. Data mapping & transparency

☐ Comprehensive inventory of personal and health data processed
☐ Documented data flows showing collection, storage, processing, sharing, and deletion
☐ Clear identification of sensitive data (health, biometric, genetic, children’s data)
☐ Accurate and accessible privacy notices aligned to actual data practices

3. Lawful basis & consent management

☐ Lawful basis identified for each category of processing in each key jurisdiction
☐ Explicit consent mechanisms in place for sensitive health data where required
☐ No bundled or “forced” consent for optional processing (e.g. marketing, analytics)
☐ Ability for users to withdraw consent easily and for systems to honour that choice
☐ Evidence of consent capture and auditability

4. Risk assessments & assurance

☐ Data Protection Impact Assessments (DPIAs / PIAs) completed for high-risk processing
☐ AI or automated decision-making risk assessments where relevant
☐ Clear mitigation actions documented and implemented
☐ Escalation process defined where residual risk remains
☐ Assessments reviewed when products or data uses change

5. Security & incident readiness

☐ Baseline security controls implemented (access control, encryption, logging)
☐ Secure development lifecycle practices in place
☐ Tested incident response plan covering data breaches and security incidents
☐ Jurisdiction-specific breach notification timelines understood and documented
☐ Evidence of regular security and privacy training for staff

6. Supplier & supply-chain assurance

☐ Inventory of all third parties and vendors with access to personal or health data
☐ Data processing agreements in place with appropriate privacy and security clauses
☐ Sub-processor visibility and approval mechanisms
☐ Periodic vendor risk reviews or audits
☐ Controls in place for SDKs, analytics tools, and embedded third-party components

7. International data transfers

☐ Clear record of where data is stored and processed globally
☐ Transfer mechanisms implemented where required (e.g. SCCs, IDTA, TIAs)
☐ Jurisdiction-specific transfer rules understood (EU/UK, India, Middle East, Caribbean)
☐ Central register of international transfers maintained and reviewed

8. AI governance & responsible use (if applicable)

☐ Inventory of AI models and automated decision systems in use
☐ Defined purpose and scope for each AI use case
☐ Controls for data used in training and inference
☐ Bias, accuracy, and performance evaluation processes
☐ Human oversight for high-impact or health-related decisions
☐ Clear user transparency about AI involvement

9. Regulated buyer & NHS readiness

☐ Evidence aligned to public sector procurement expectations
☐ NHS DSP Toolkit position understood and achievable
☐ Alignment with NHS DTAC data protection and cyber security criteria
☐ Ability to respond quickly to security and privacy due-diligence questionnaires
☐ Audit-ready documentation available on request

10. Medical device & federal healthcare pathways (where relevant)

☐ Clear understanding of whether the product qualifies as SaMD
☐ Privacy and security risks addressed as part of product lifecycle management
☐ Documentation supporting safety, effectiveness, and post-market monitoring
☐ HIPAA-aligned controls in place where selling into US healthcare environments
☐ Evidence suitable for FDA, MHRA, or equivalent regulatory review

How to use this checklist

• Mostly ticked? You are likely well-positioned to engage regulated buyers and progress through formal assurance processes.
• Several gaps? These are common for growing health tech companies and can usually be addressed quickly with a structured, risk-based approach.
• Unsure how to evidence items? That uncertainty itself is often what delays procurement or regulatory approval.

Failing to get the ticks you need? Contact us to find out how we can help.