What 2025 Taught Us About Digital Health Compliance And What Will Matter in 2026

2025 was a pivotal year for digital health compliance. This year, healthcare technology rapidly evolved which forced organisations to confront new regulatory challenges and refine their approaches to data security, privacy, and patient safety. As digital health startups scaled and healthcare providers adopted more tech solutions, compliance became a leadership priority. In reflecting on the past year, several clear lessons emerged that will shape how we approach compliance moving forward.

Lessons from 2025 in Digital Health Compliance

The past year revealed key insights into what works and what doesn’t in managing compliance for digital health organisations. Here are some of the standout lessons from 2025:

Trust Through Standards Became Non-Negotiable

In 2025, demonstrating ISO 27001 compliance and robust data protection became essential even for growth-stage digital health companies. Achieving and maintaining this internationally recognised standard signaled to partners and customers that an organisation takes information security seriously. At the same time, privacy remained paramount. Many teams adopted a detailed GDPR compliance checklist to ensure they met every requirement for handling patient data. This methodical approach to privacy not only helped avoid regulatory fines but also built trust with users in an era of heightened awareness around data breaches.

Healthcare-Specific Regulations Came to the Forefront

Beyond general security and privacy standards, 2025 highlighted the importance of industry-specific compliance frameworks. For companies integrating with NHS systems or handling NHS patient data, NHS DSPT compliance was mission-critical. The NHS’s evolving Data Security and Protection Toolkit (transitioning to a new Cyber Assessment Framework) raised the bar for what’s expected of digital health suppliers. Likewise, ensuring product safety became a key theme. The DCB 0129 clinical safety standard gained prominence. Digital health innovators learned that meeting DCB 0129 requirements (such as having a Clinical Safety Officer and rigorous safety cases) is not just a bureaucratic exercise, but a necessary step to ensure technology-driven care remains safe and effective.

Manual Compliance Management Hit Its Limit

Another lesson from 2025 was the inefficiency of juggling multiple frameworks with traditional tools. Many organisations started the year tracking controls and policies in spreadsheets and manual documents, only to find this approach buckling under growing complexity. With overlapping obligations across ISO 27001, GDPR, NHS standards and more, teams found that a siloed approach led to duplicate work and potential gaps. In response, we saw greater adoption of automated compliance software to streamline these efforts. Platforms capable of handling various requirements in one place emerged as game-changers. By using a multi-framework compliance tool, companies could map one set of actions or evidence to multiple standards at once, reducing duplication and ensuring nothing fell through the cracks. The result was not only saved time, but also greater confidence that compliance tasks were being handled consistently.

SMEs Embraced Structured Risk Management

2025 taught even smaller digital health players that no one is too small for a serious compliance mindset. Startups and SMEs, often without dedicated compliance departments, realised that proactively managing risks can’t be an afterthought. Many leaned on risk assessment templates for SMEs to jump-start their risk management processes. These templates provided a structured way to identify threats and vulnerabilities, from cyberattacks to clinical safety issues and to prioritise mitigation steps. For resource-strapped teams, this approach was invaluable. It allowed them to align with best practices from standards like ISO 27001 (which emphasises risk-based security) without having to reinvent the wheel. The outcome: SMEs became more resilient and prepared, turning compliance from a scramble at audit time into an ongoing business practice.

What Will Matter in 2026

As we look ahead, the coming year promises to build on these lessons with even higher expectations. Digital health companies in 2026 will face an environment where compliance is more intertwined with competitiveness and trust than ever. Here’s what will matter most:

Continued Focus on Security and Privacy Compliance

The foundational work of securing data and protecting privacy will only intensify. In 2026, maintaining certifications and a proven security posture is expected to be a baseline for doing business. ISO 27001 will remain a must-have for credibility, and organisations will need to keep their information security management systems up-to-date with the latest threats and controls. On the privacy side, regulators are not relenting – we can anticipate stricter enforcement of GDPR principles and perhaps updates to health-specific data protection guidelines. Companies will continue to rely on comprehensive GDPR compliance checklists and regular audits to ensure no aspect of patient data handling is overlooked. In the UK, the NHS’s requirements are evolving, but the need for full DSPT compliance remains a gatekeeper for working with the health service. The bottom line is that strong security and privacy practices are core to patient trust and partnership deals.

Integration of Multiple Compliance Frameworks

If 2025 was about coming to grips with various frameworks, 2026 is about seamlessly integrating them. The ability to demonstrate compliance across multiple standards, often simultaneously, will be a key differentiator. Whether it’s aligning NHS DSPT compliance efforts with your ISO 27001 controls, or ensuring your product meets both cybersecurity and clinical safety benchmarks, a unified approach is crucial. We expect to see more organisations adopt platforms or multi-framework compliance tools that give a consolidated view of their obligations. This means less time spent manually cross-referencing standards and more time actually improving compliance outcomes. An integrated compliance strategy not only eases the burden of audits and questionnaires, it also provides assurance to stakeholders (like hospital customers or investors) that the company has a holistic program covering all bases.

Automation and Continuous Compliance Monitoring

Gone are the days of annual tick-box audits, 2026 will emphasise continuous, proactive compliance. With threats evolving weekly and standards updating frequently, relying solely on humans to keep pace is impractical. Automated compliance software will play an even bigger role in the coming year. By automatically tracking policy updates, monitoring system configurations, and alerting teams to issues, these solutions enable organisations to fix gaps before they become problems. Automation also helps maintain an evidence trail effortlessly, crucial when you need to prove compliance at the drop of a hat. Digital health firms that invest in automation and integration (for example, linking their cloud platforms, logs, and workflows into a central compliance dashboard) will find it much easier to stay audit-ready. The focus will shift from reactive, last-minute preparations to ongoing assurance, allowing teams to spend more time on innovation and less on paperwork.

Proactive Risk and Safety Management as a Culture

Finally, 2026 will reward those who embed risk and patient safety considerations into their daily operations. Instead of treating risk assessments as a one-time paperwork exercise, leading companies will make them a continuous process. This cultural shift means regularly updating risk registers, reviewing incidents (or near-misses) for lessons, and refining controls accordingly. Tools like standardised risk assessment templates for SMEs will continue to help smaller organisations maintain this cadence without heavy overhead. Meanwhile, the emphasis on patient safety, through standards like DCB 0129 is only growing. Regulators and healthcare partners may ask for evidence that clinical risks have been assessed and mitigated throughout the product lifecycle. Digital health companies that foster a culture of “compliance by design,” where every team member understands the importance of safeguarding data and patients, will be best positioned to thrive.

In conclusion, the journey through 2025 underscored that compliance is a strategic imperative in digital health. As we enter 2026, the stakes are higher, but so are the opportunities for those who adapt. By building on the lessons of last year, embracing recognised standards, leaning into automation, integrating frameworks, and keeping risk management front and center, digital health innovators can not only meet their compliance duties but also gain a competitive edge. In an industry built on trust and innovation, the winners will be those who view robust compliance not as a hurdle, but as an enabler of sustainable growth and impact.

Naq helps digital health companies simplify compliance across NHS, private, and international markets. With automated evidence collection, multi-framework mapping, and continuous oversight, Naq gives teams the tools they need to stay audit-ready.

Find out how Naq can support your growth in 2026 at https://www.naqcyber.com/company/contact

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