Digital health technology is becoming increasingly commonplace, helping to transform patient care pathways, boosting health and wellbeing, making health systems more efficient, delivering cost savings and empowering people to manage their own conditions more successfully.

Virtual care is capable of reaching significantly more people than in-person appointments, but there are some concerns about healthcare digitisation, particularly from the perspective of businesses operating in this sector, which demands consistent service delivery and proactive risk management.

Digital health solutions of all kinds, including the likes of software as medical devices, artificial intelligence as medical devices, 3D printing, mobile apps, virtual assistants, wearable medical devices, robotics and virtual care provision, must remain compliant with all relevant regulations and standards, including DCB 0129, the Data Security and Protection toolkit and Digital Technology Assessment Criteria.

These standards (among others) serve to ensure that products, processes and systems are secure, robust, accessible and clinically safe – but it’s important to note that they don’t cover complete organisational structures, so it may be beneficial to investigate ISO 9001 certification as well.

ISO 9001

The ISO 9001 standard is currently undergoing major amendments (having been left unchanged for ten years or so), with the expected updates now delayed until September 2026… so it’s perhaps fair to say that they’re likely to be quite significant.

As such, now’s the perfect time to prepare for potential changes and it’s likely that there will be even greater focus placed on digital transformation.

This particular standard isn’t industry-specific, but it is highly relevant to those businesses working in digital health. Certification will ensure that your organisation has a clear framework in place to deliver your products and services consistently, and efficiently, as well as driving improvements as appropriate over time.

You’ll also find that your approach to risk management is properly supported, improving both the patient experience and your organisation’s activities, and making sure that your business is able to maintain this as you grow and thrive.

What about ISO 13485?

If you’re involved in the design, production and servicing of medical devices, you’ll need to consider ISO 13485 certification to ensure patient safety and compliance with regulations.

This would be a good option if you’re keen to tick all the ISO 9001 boxes but want to be particularly vigilant and ensure compliance as your products and services develop.

What regulatory changes can we expect?

As digital health technologies continue to emerge, with key innovations including the likes of mobile health apps, connected wearable devices, digitised health systems, patient data and prescription delivery, telemedicine, health data analytics, personalised medicine and both AI and machine learning (ML), regulations are certain to evolve to ensure that safety, quality and performance standards continue to be met.

Key areas of focus include data protection and privacy, ensuring compliance with GDPR by safeguarding patient data. Medical device regulation (prioritising safety, quality and performance of tech), telemedicine and remote care, and clinical safety and effectiveness continue to be of particular importance for businesses.

Finally, cybersecurity is another area of focus that companies would be wise to put at the top of the agenda, making sure that health data is secure and the appropriate levels of protection against cyber attacks are implemented.

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Find out more…

If you’d like to find out more about the evolving digital health landscape and what you can do to prepare for regulatory changes, please contact us on 0333 014 7720 or email info@isocertonline.net.