Top Digital Health Compliance Standards to Watch in 2025

The digital health sector is always transforming, usually driven by advancements in AI management and increasingly stringent cybersecurity requirements. As technology becomes more integral to healthcare, digital health companies face growing pressure to navigate complex compliance standards.

In this blog, we explore the essential standards for 2025, the primary challenges innovators encounter, and some practical guidance to stay ahead of the curve.

Remember this journey is more than just a checklist exercise. A survey of over 50 health tech innovators reveals that compliance has emerged as a formidable challenge, with "compliance burnout" becoming a prevalent concern across the industry.

Top Compliance Standards for 2025

Here are the five standards that digital health organisations are focusing on the most:

1. ISO 42001 – AI Management Systems (55%)

What it is: New international standard for managing AI responsibly (fairness, transparency, security).

Why it matters: AI is becoming a huge part of healthcare — and regulators are watching closely.

2. UK Cyber Essentials (51%)

What it is: A government-backed certification to guard against common cyber threats.

Why it matters: Essential for NHS partnerships and securing patient data.

3. NHS Data Security and Protection Toolkit (DSPT) (48%)

What it is: Self-assessment to prove you handle patient data safely.

Why it matters: Mandatory if you want to work with the NHS.

4. ISO 27001 – Information Security Management (44%)

What it is: Global gold standard for information security.

Why it matters: Critical when dealing with sensitive patient and clinical data.

5. DTAC – NHS Digital Technology Assessment Criteria (41%)

What it is: A full checklist for clinical safety, cybersecurity, and usability.

Why it matters: A "stamp of approval" is needed for digital products entering NHS systems.

But Compliance Isn’t Easy...

The State of Digital Health Compliance 2024, highlights four key challenges innovators face​:

1. Understanding What’s Required (62%)

   Too many frameworks, unclear expectations, and a flood of new entrants to the sector create confusion.

2. Lack of Capacity (61%)

   Small teams struggle to find time to answer hundreds of compliance questions while also building great products.

3. Budget Pressure (47%)

   Companies spend an average of £18,700 per year just on compliance — excluding internal staffing time!

4. Complex Documentation (42%)

   Navigating disconnected, evolving regulations makes tracking proof of compliance a major pain point.

How Are Digital Health Companies Managing Compliance?

• 57% manage compliance internally with no dedicated teams.

• Only 20% have dedicated compliance officers or teams.

• Main worries: Losing contracts and the fear of legal action​.

The sector is asking for more automation, better tools, and clearer guidance to avoid bottlenecks — and burnout.

What Compliance Will Look For The Rest Of 2025

More companies are aiming to meet additional standards in 2025, including:

• Cyber Essentials Plus (advanced cybersecurity)

• DTAC (NHS tech standard)

• ISO 27001 (data security)

• HIPAA (for US expansion)

• FDA and MDR (for medical devices)

There's also a big push to prepare for the NHS DSPT’s move towards the Cyber Assessment Framework (CAF) — putting cybersecurity outcomes front and centre​.

And yes — companies are looking across the Atlantic. More UK innovators plan to enter the US market in 2025, doubling interest in US standards.

Practical Tips from NHS Innovation Leaders

Some advice from innovators who’ve successfully tackled compliance:

Start with mandatory requirements first, then tackle “nice-to-haves.”
Break down big tasks into weekly goals to avoid overwhelm.
Network with other innovators to swap advice and resources.

Find early partner organisations who understand your compliance journey.

How to Lighten the Compliance Load

At Periculo, we provide a managed security service designed to ease your compliance burden, potentially saving you up to £30,000 annually.

Final Thoughts

Digital health companies are changing lives — but unless they solve the compliance puzzle, growth will stall.

The winners of 2025 will be those who treat compliance not as a burden but as a competitive advantage — showing they are secure, ethical, and trustworthy partners in healthcare.

Get in touch today to explore how you can simplify compliance, unlock new opportunities, and focus on what matters most: improving patient outcomes.

_References

_{The State of Digital Health Compliance 2024 Report – Published by Naq Cyber}

_{National Cyber Security Centre (NCSC) – "Cyber Essentials Certification"
Cyber Essentials Overview}

_{International Organisation for Standardisation (ISO) – "ISO 42001:2023 Artificial Intelligence Management Systems"
ISO 42001 Information}

_{NHS England – "Digital Technology Assessment Criteria (DTAC)"
DTAC Full Guidance}