Trust & Compliance
Readiness for U.S. health systems
Security, privacy and implementation assurance adapted for US buyers — with clear boundaries on regulated use.
What we provide
US-oriented assurance
- Security and privacy notes (incl. HIPAA considerations, BAAs where relevant)
- Clear boundary between reference tools and regulated clinical use
- Implementation and change-management checklist
- Evaluation outputs adapted to your buyer's framework
Note. US regulatory matters (FDA classification, state-specific law) require your own counsel; we provide assurance support and work alongside them.
Why our approach travels
Discipline built for a regulated market
Meds Global Health is a UK-rooted medical-intelligence company, and that origin is an advantage when selling into the United States. The NHS market is one of the most demanding assurance environments in the world: a digital-health product cannot reach a ward without clinical-safety evidence, a defensible privacy position and accessibility conformance. The habits that environment forces — explicit intended-use boundaries, documented risk management, named accountability and dated review — are precisely the habits US health-system security reviews, privacy offices and clinical committees reward.
What changes for a US buyer is not the rigour but the framework and the vocabulary. We take the structured evidence we would assemble for an NHS procurement and re-express it against US expectations: HIPAA's privacy and security rules in place of UK GDPR Article 9 conditions, the Business Associate relationship in place of UK data-processing agreements, and your buyer's own vendor-risk questionnaire in place of the NHS Data Security and Protection Toolkit. The control intent is largely shared; we make sure the documentation speaks the language each reviewer reads.
Where regulatory determinations are involved — FDA device classification, state telehealth or licensure rules, or sector-specific obligations — we do not substitute for your counsel. We make those conversations faster by giving your advisers a clean description of intended use, the line your product draws against autonomous clinical decision-making, and the evidence that supports it.
How an engagement runs
From scoping to a buyer-ready pack
- Scope and intended use. We agree what the product is for, the clinical or operational claim it makes, and — crucially — what it does not do, so the regulated-use boundary is unambiguous from the start.
- Privacy and security mapping. We map your data flows and document HIPAA considerations, the Business Associate position where relevant, encryption and access controls, and processor due diligence in a form a US security team can assess.
- Evidence adaptation. We translate clinical-safety and quality evidence — the same substance we would prepare under DCB0129 manufacturer safety thinking — into your buyer's framework and questionnaire.
- Implementation and change management. We produce a rollout and oversight plan so the deploying health system understands configuration, training, monitoring and the route for raising issues.
- Review readiness. We package everything so a vendor-security review, privacy assessment and clinical sign-off can proceed without repeated requests for missing documentation.
This mirrors the structure we use for UK clients on our NHS Buyer Readiness pathway, and complements the governance discipline described in AI Governance & Oversight — both of which underpin a credible US story.
Answers
Frequently asked questions
Do you understand US procurement and compliance?
We support US health systems on security, privacy (including HIPAA considerations and BAAs where relevant), and implementation readiness, and we are explicit about the boundary between information/reference tools and regulated clinical use. For formal regulatory matters (FDA, state law), we work alongside your counsel.
Can you tailor assurance for a US deployment?
Yes — we adapt our evaluation and governance outputs to US frameworks and your buyer's requirements, with a clear implementation checklist.
How does your UK methodology translate to US buyers?
The underlying discipline travels well. Our clinical-safety approach (modelled on DCB0129/DCB0160 thinking) maps onto the risk-management expectations US health systems hold, and our data-protection rigour translates into HIPAA-aligned privacy and security narratives. We re-frame the same evidence into the vocabulary your US buyer, IT security review and privacy office expect.
Do you make FDA medical-device determinations?
No. Whether software is a regulated device under FDA rules is a determination for you and your regulatory counsel. We help you articulate intended use, the boundary against clinical decision-making, and the supporting documentation, but the classification decision and any submissions remain yours.
What does a US-ready assurance pack contain?
Typically a security and privacy summary (HIPAA considerations, BAA position, data-flow description), an intended-use and limitations statement, an implementation and change-management plan, accessibility notes, and evidence adapted to your buyer's vendor-risk questionnaire. We assemble it so a security review can move quickly.
Selling into US health systems?
We'll help you assemble the assurance US buyers expect.