Digital Health in 2025: Software Validation, Cybersecurity, and Global Market Access

Digital health is no longer a niche within the medical device sector. Software-enabled technologies now span the continuum of care: diagnostic algorithms, connected wearables, telehealth platforms, clinical decision support tools, and mobile health applications. This digital transformation has created unprecedented opportunities but also significant regulatory and compliance challenges.

In 2025, regulators around the world have sharpened their focus on digital health. The FDA has refined its guidance on software as a medical device (SaMD) and cybersecurity. The European Union is enforcing strict requirements under MDR, IVDR, and preparing for the AI Act. Other regions, from China to Brazil, are aligning with international standards while adding local requirements.

For manufacturers, the message is clear: digital health compliance must be robust, evidence-driven, and global in scope. This blog explores key regulatory expectations in 2025, common pitfalls, and strategies executives should adopt to achieve and maintain market access.

Regulatory Landscape

United States

The FDA regulates digital health through multiple frameworks:

• Software as a Medical Device (SaMD): FDA follows IMDRF principles for classification and evidence. Documentation must include software requirements, hazard analysis, and verification and validation (V&V).

  
  

• Cybersecurity: Since 2023, submissions must include cybersecurity risk management plans, SBOMs, and maintenance strategies. FDA has authority to refuse submissions lacking this information.

  
  

• Predetermined Change Control Plans (PCCPs): For AI/ML-enabled devices, manufacturers can predefine updates without resubmitting if the PCCP is approved. This framework is becoming central to AI submissions.

  
  

• Human Factors: FDA places strong emphasis on usability testing for digital tools, particularly those used directly by patients.

  
  

European Union

The EU regulates software under MDR and IVDR:

• Rule 11 of MDR: Most diagnostic or therapeutic software is classified as Class IIa or higher, requiring Notified Body review.

  
  

• Clinical Evaluation: Digital devices require clinical evaluation, often supported by real-world performance data.

  
  

• AI Act: By 2026, high-risk AI software must comply with additional requirements for transparency, bias mitigation, and human oversight.

  
  

• Cybersecurity: Annex I of MDR requires manufacturers to address cybersecurity risks. Guidance documents published in 2024 set expectations for SBOMs, vulnerability disclosure, and secure design.

  
  

Other Markets

• China: NMPA requires local testing and data for digital devices and is phasing in UDI requirements.

  
  

• Brazil: ANVISA regulates SaMD under RDC 657, aligning with IMDRF principles.

  
  

• Japan and Australia: Both regulators closely follow IMDRF guidelines but may require local evidence.

  
  

Why Digital Health Compliance Is Challenging

1. Rapid Iteration: Software evolves faster than traditional devices. Regulatory processes can struggle to keep pace.

   
   

2. Cybersecurity Risks: Constant updates and new vulnerabilities make lifecycle cybersecurity management essential.

   
   

3. Data Privacy: Digital health products collect sensitive patient data, raising compliance obligations under GDPR, HIPAA, and other privacy laws.

   
   

4. Evidence Expectations: Regulators expect not just technical validation but also clinical performance data, which can be harder to generate for software.

   
   

5. Global Variation: While IMDRF provides a framework, local regulators impose unique requirements.

   
   

Common Pitfalls

• Incomplete V&V Documentation: Many companies underestimate the level of detail required in software validation records.

  
  

• Weak Cybersecurity Evidence: Submissions lacking penetration testing or SBOMs are being refused.

  
  

• Over-Reliance on Bench Testing: For clinical performance, regulators expect real-world evidence or trials, not just bench validation.

  
  

• Neglecting Human Factors: Apps or devices that are not intuitive for patients face usability-related delays.

  
  

• Fragmented Global Strategy: Companies often approach submissions market by market, duplicating effort and introducing inconsistencies.

  
  

Case Examples

• RTA for Missing Cybersecurity: A digital diagnostics firm submitted a 510(k) for an AI-powered ECG interpretation tool. The submission lacked a SBOM. FDA refused to accept it, delaying clearance by six months.

  
  

• NB Nonconformity: A mobile health app manufacturer under MDR failed to provide adequate clinical evaluation data. The Notified Body required a post-market clinical follow-up study, delaying certification.

  
  

• Success with PCCP: A U.S. start-up building an AI radiology tool submitted a robust PCCP outlining planned algorithm updates. FDA approved the PCCP, allowing the firm to continuously improve its model post-clearance without resubmitting.

  
  

Practical Steps for Manufacturers

1. Strengthen Software Validation: Follow IEC 62304 for software lifecycle processes. Ensure complete traceability from requirements to test results.

   
   

2. Embed Cybersecurity in Design: Conduct threat modeling early. Document penetration testing, vulnerability management, and update mechanisms.

   
   

3. Plan Clinical Evidence Strategies: Align with MDR requirements by combining bench validation with real-world evidence or targeted clinical studies.

   
   

4. Integrate Privacy by Design: Ensure GDPR, HIPAA, and local privacy compliance. Build consent and data protection features into the software.

   
   

5. Focus on Usability: Conduct formative and summative human factors studies. Document design changes based on user feedback.

   
   

6. Adopt a Global Core Dossier: Prepare a technical file aligned with IMDRF that can be adapted to multiple markets, reducing duplication.

   
   

7. Engage Regulators Early: Use pre-submissions with FDA or consultations with Notified Bodies to confirm strategies before investing heavily in studies.

   
   

Strategic Implications for Executives

For CEOs

Digital health is a growth engine, but regulatory missteps can stall launches and erode investor confidence. CEOs should prioritize building digital compliance expertise and allocate sufficient resources to QA/RA teams.

For QA/RA Leaders

QA/RA leaders must manage rapidly evolving guidance, harmonize submissions across regions, and ensure cybersecurity is treated as part of quality systems.

For Product and R&D Leaders

Software teams must adopt development lifecycles that anticipate regulatory expectations. This includes embedding validation, usability, and cybersecurity processes early.

For Operations and Commercial Leaders

Market access increasingly depends on proving compliance with cybersecurity and privacy requirements. Procurement teams at hospitals and health systems now ask for cybersecurity attestations as part of vendor evaluations.

Final Thoughts

In 2025, digital health success depends on mastering compliance. Software validation, cybersecurity, clinical evidence, and privacy are no longer optional extras, they are essential for market access. Companies that build regulatory strategies into their development processes can bring innovations to market faster, with fewer surprises.

How PRP Compliance Can Help: We help companies validate software under IEC 62304, prepare cybersecurity documentation, and design clinical evidence strategies for global submissions. Contact PRP Compliance to ensure your digital health products are compliant, secure, and ready for global markets.