What Will Define Success in Digital Health in 2026?
Success in digital health in 2026 will hinge on three pillars: readiness, credibility, and strategic planning. Companies that treat compliance as a foundation for growth will get ahead. In practice, this means being fully audit-ready with all regulatory checklists and certifications in place, building trust through continuous evidence and cybersecurity, and planning for future markets and rules. As Naq observes, selling into healthcare comes with a non-negotiable requirement: compliance and without it, no product makes it past procurement. Leaders who integrate compliance into their business strategy will unlock faster NHS and global procurement and turn regulation from a burden into a competitive advantage.
Readiness: Operational Maturity and Regulatory Preparedness
Success in digital health in starts with operational maturity. Digital health organisations in 2026 are expected to have the full compliance foundation in place before a procurement conversation begins. In the UK, this means being able to demonstrate both NHS DSPT compliance and DTAC compliance from day one.
The Data Security and Protection Toolkit (DSPT) is an annual self-assessment that shows an organisation protects NHS patient data in line with national standards. It aligns closely with GDPR requirements and focuses on information governance, cybersecurity controls, and safe data handling. Alongside DSPT, the Digital Technology Assessment Criteria (DTAC) acts as a mandatory gateway for NHS adoption. DTAC assesses five core areas: clinical safety, data protection, cybersecurity, interoperability, and usability. Without DTAC compliance, even technically strong products are unlikely to progress through NHS onboarding or procurement. Where a product has a direct impact on patient care or clinical decision-making, organisations must also be prepared to evidence compliance with the DCB 0129 clinical safety standard, including a formal clinical safety case and an appointed Clinical Safety Officer.
Beyond NHS-specific frameworks, broader compliance certifications play an increasingly important role in demonstrating readiness. ISO 27001 certification has become the global benchmark for information security management and is now prioritised by over half of digital health innovators. Achieving ISO 27001 signals to NHS buyers, private providers, and international partners that robust cybersecurity controls are embedded across the organisation. Similarly, ISO 9001 requirements, while not healthcare-specific, provide assurance that a company operates under a structured quality management system with consistent processes and continuous improvement. Many digital health companies use ISO 9001 to strengthen credibility with enterprise customers and procurement teams.
Data protection remains non-negotiable. A comprehensive GDPR compliance checklist is essential for meeting UK and EU data protection obligations and is frequently reviewed during NHS and enterprise procurement. This includes appointing a Data Protection Officer where required, maintaining GDPR-aligned privacy notices, ensuring lawful bases for processing patient data, implementing staff training, and having clear incident and breach-response procedures in place. These elements are not only regulatory requirements, but also practical indicators of organisational maturity.
Meeting these frameworks proactively, rather than reacting to them during audits, is what defines readiness in digital health. As Naq consistently sees across NHS and private healthcare markets, organisations that can demonstrate compliance immediately move through procurement faster and with less friction. In 2026, readiness will involve having the entire compliance foundation built, maintained, and visible in real time rather than treated as a one-off exercise, but as a core operational capability that supports sustainable growth.
Credibility: Evidence Generation, Cybersecurity and Trust Signals
Once the foundational compliance requirements are in place, success in digital health depends on credibility. Healthcare buyers, regulators, and investors all require assurance that a solution is safe, reliable, and well governed. This assurance is built through continuous evidence of compliance and strong cybersecurity practices. Certifications, audit outputs, and security controls function as visible trust signals that show how an organisation meets and maintains high regulatory and operational standards.
In regulated healthcare markets, cybersecurity certifications are a basic requirement. Recognised standards such as ISO 27001 and Cyber Essentials Plus are now expected across NHS, private healthcare, and enterprise procurement. ISO 27001 remains the global benchmark for information security management, Cyber Essentials Plus, the independently audited version of the UK government’s Cyber Essentials scheme, is increasingly requested for higher-risk contracts and environments involving sensitive patient data. While Cyber Essentials is required for DSPT, Cyber Essentials Plus is often expected where additional assurance is needed. Holding these certifications sends a clear message to NHS and enterprise buyers that security is taken seriously and embedded across the organisation.
However, credibility is not established by certifications alone. Organisations must also be able to demonstrate ongoing compliance in practice. This is where compliance dashboards and centralised governance, risk, and compliance platforms play a critical role. A well-designed compliance dashboard consolidates and visualises compliance data, providing real-time insight into how an organisation is performing against multiple frameworks. Rather than relying on static documentation, teams can track audit readiness, control implementation, and risk assessments continuously. For leadership teams, this visibility transforms compliance into actionable operational intelligence.
Systematic risk management further strengthens credibility. Modern compliance platforms increasingly incorporate risk metrics, such as the number of open risks, severity ratings, and mitigation progress. Converting traditional risk registers into live risk scores allows teams to prioritise the most critical issues and address them proactively. This approach aligns with expert predictions that by 2026, the language of risk and compliance will converge across organisations, particularly at board level. Senior decision-makers increasingly expect to see how compliance activity directly mitigates business, clinical, and cyber risk. Integrated risk management software enables organisations to communicate in those terms, demonstrating maturity and control rather than reactive compliance.
Recognised certifications, documented evidence, real-time dashboards, and live risk metrics provide regulators and buyers with confidence. For NHS organisations operating under significant delivery pressure, DTAC itself is widely recognised to offer assurance that a product can be deployed without introducing hidden risks or delays. In practice, success increasingly belongs to digital health companies that do more than pass audits. The organisations that stand out are those that can prove their compliance continuously, transparently, and at scale, turning credibility into a genuine competitive advantage.
Long-Term Planning: Multi-Market Scalability, Risk Management and Futureproofing
While readiness and credibility determine whether a digital health company can enter regulated markets, long-term success in 2026 will focus on whether it can scale without introducing friction, cost, or risk. High-performing teams are embedding compliance into their growth strategy and technology roadmap, treating it as infrastructure that supports expansion rather than a series of isolated projects.
Multi-market scalability is central to this shift. Companies that have invested early in UK and EU frameworks such as NHS DSPT, DTAC, GDPR and ISO 27001 are far better positioned to expand internationally without rebuilding compliance from scratch. Much of the evidence, controls and governance required to operate in the NHS can be reused or adapted for other regulated markets, including the US. For example, organisations already compliant with ISO 27001 and DSPT are largely well-positioned to meet many HIPAA requirements, with targeted adjustments rather than wholesale change. In 2026, global growth will favour companies that design compliance as a reusable system, not a market-by-market exercise.
Regulatory foresight is becoming just as important as regulatory execution. Digital health leaders are no longer waiting for new rules to land before responding. Instead, they are preparing in advance for emerging regulatory domains, particularly AI governance. Standards such as ISO 42001 are already being adopted by forward-thinking teams as a way to establish structured oversight of algorithmic risk, transparency and accountability. This proactive approach allows organisations to absorb new regulations, such as the EU AI Act, without disruption, turning regulatory change into a strategic advantage rather than a last-minute scramble. The same principle applies to ongoing NHS changes, including the evolution of DSPT and refinements to DTAC, where early awareness and preparation accelerate market access.
Long-term planning also requires a shift from periodic compliance activity to continuous risk management. By 2026, risk and compliance data is increasingly converging at board level, reframing compliance as a driver of operational resilience and commercial confidence. Rather than relying on annual audits, leading organisations are investing in systems that track risks, controls and third-party dependencies in real time. This enables executives to understand where risk sits across the business, prioritise mitigation, and demonstrate governance maturity to buyers, partners and investors. As regulatory expectations expand to include supply-chain resilience, this visibility becomes essential.
Compliance as Competitive Advantage
Underpinning success in regulated healthcare markets is the shift towards a unified compliance infrastructure. Managing multiple frameworks through disconnected spreadsheets and one-off documents does not scale sufficiently. In contrast, multi-framework compliance platforms enable teams to centralise policies, evidence, training and risk registers across standards such as DSPT, DTAC, ISO 27001, GDPR and HIPAA. This approach transforms expansion into a repeatable process. Adding a new market or regulatory requirement becomes a matter of configuration rather than reinvention, reducing operational overhead while keeping organisations continuously audit-ready.
The digital health companies that succeed in 2026 will be those that design compliance for scale. By embedding regulatory foresight, reusable controls and ongoing risk management into their operating model, they expand faster, adapt to change with confidence and avoid the friction that slows less prepared competitors. Futureproofing compliance is not about doing more work, but about building smarter foundations that support growth without disruption.
How Naq Enables Digital Health Teams to Stay Ahead in 2026
Naq was built specifically to support the realities of regulated healthcare. Our platform brings all compliance activity into one place, allowing teams to manage NHS, private and international frameworks side by side without duplication. From DSPT, DTAC and DCB 0129 to ISO 27001, GDPR, HIPAA and emerging standards, Naq maps overlapping requirements so evidence can be reused across frameworks rather than recreated. Automated workflows, centralised risk management and real-time visibility ensure teams remain audit-ready as regulations evolve, while expert oversight helps organisations interpret change and plan ahead with confidence. In practice, this means fewer delays, faster procurement, and compliance that actively supports growth rather than holding it back.Wo
Audit-readiness and proactive compliance will be commercial imperatives in the year ahead. Organisations that demonstrate operational maturity, continuous evidence and strong cybersecurity posture, while planning early for new markets and emerging regulation, will hold a clear advantage. They will spend less time reacting to audits and regulatory changes, and more time innovating, selling and scaling. In regulated healthcare, staying ahead of standards is what defines success.
Find out how Naq’s compliance automation platform helps digital health teams stay ahead https://www.naqcyber.com/company/contact
