FAQ
Frequently Asked Questions
How long does a typical advisory engagement take?
It depends on the scope. A DTAC self-assessment support engagement typically runs 4–6 weeks. A full DCB0129 clinical safety documentation package is usually 6–10 weeks. CSO outsourcing is structured as a monthly retainer with no fixed end date. We scope every engagement at the discovery call so you know exactly what to expect before we start.
Do you work with early-stage digital health startups?
Yes — and it is where early investment in compliance pays off most. Many founders wait until a procurement opportunity arises before addressing regulatory requirements, which costs time and deals. We help early-stage teams build the right foundations from the start so compliance becomes a commercial asset, not a last-minute hurdle.
Can you support NHS procurement submissions directly?
Yes. We support teams through NHS and ICB procurement processes including tender preparation, compliance evidence mapping, and DTAC submission. We understand what commissioners look for and how to structure evidence to meet those expectations.
What is DCB0129 and do I need it?
DCB0129 is the NHS clinical risk management standard for health IT systems. If your product is used in a clinical setting, interfaces with patient data, or is being procured by an NHS organisation, you almost certainly need it. It requires a documented clinical safety case, a hazard log, and sign-off by a qualified Clinical Safety Officer. We handle all of this.
What is DTAC and which products need it?
DTAC — the Digital Technology Assessment Criteria — is the NHS framework used to assess digital health products before procurement. It covers 14 standards across clinical safety, data protection, technical security, interoperability, and usability. Any product seeking NHS procurement needs to meet it. We provide end-to-end DTAC advisory from gap analysis to submission.
Do you work with international clients outside the UK?
Yes. We advise international digital health companies seeking to enter the UK market — covering regulatory positioning, DTAC readiness, NHS procurement strategy, and clinical safety requirements. We also support GCC-based health technology investors and health system buyers navigating the UK digital health landscape.
What happens after the initial discovery call?
Within one business day of your call, we send a written summary of your regulatory position and a proposed engagement scope. If you are ready to proceed, we issue a fixed-scope agreement and begin onboarding. There is no obligation after the discovery call — it is purely a diagnostic conversation.
Can you review compliance documentation we have already started?
Yes. We regularly step into engagements mid-stream — reviewing existing hazard logs, safety cases, DTAC evidence packs, and regulatory submissions. We identify gaps, correct errors, and get your documentation to a standard that holds up under scrutiny. You do not need to start from scratch to work with us.
What makes SDHA different from other digital health advisory firms?
Every engagement is led by a GMC-registered, DCB0129-qualified practising clinician who has reviewed NHS digital health procurement submissions from the inside. That dual perspective — clinical authority combined with procurement experience — is what separates our advisory from compliance consultants who understand the standard but have never sat in the room where buying decisions are made.
What is SDHA's origin story?
SDHA was founded by Dr Jide Idowu, a practising UK clinician with direct experience reviewing digital health submissions in NHS and global procurement settings. Having seen repeatedly how strong products failed not because of technology but because of incomplete compliance documentation, he founded SDHA to make that clinical safety expertise accessible to the companies that need it most.
What is your mission?
To close the gap between clinical rigour and digital health strategy. We exist to ensure that digital health products with genuine patient benefit are not lost to procurement processes because the compliance documentation was not built to the standard commissioners require.
What if we are not sure which service we need?
Book a discovery call. We will map your regulatory position, identify your obligations, and recommend the right advisory approach for your product and timeline. Most clients come to us unsure of exactly what they need — that is what the discovery call is for.
Still have questions?
Let’s talk.
If you did not find the answer you need, we are here to help. We will map your regulatory position, answer your questions, and help you identify the right next step for your product.
How we can help
We are here to answer your questions, understand your needs, and help you choose the right next step.
- Answer questions about our services
- Recommend the best next step
- Clarify your regulatory obligations
- Discuss timelines, scope, and fit
