Perspectives: Creating consistent standards isn’t a once and done job

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today’s contribution is from Rhod Joyce, Deputy Director of Innovation Development at NHS Transformation Directorate and previously Head of Partnerships for NHSX. As Deputy Director of Innovation Development within the NHS Transformation Directorate, Rhod works to support the ecosystem in the development, assurance, and deployment of digital tools and services at scale. Key programs include the Digital Health Partnership Award and the Digital Health Technology Assessment Criteria. He drives support for patients to access digital health apps to support the management of long-term conditions and leads the Transformation Directorate’s Partnerships team.

This is the second Perspectives contributed by Wysa, an AI-enabled therapy coach for mental and emotional wellness. It recently was granted an FDA Breakthrough Device Designation prior to premarket review. 

Interested contributors should contact Editor Donna. (Pictures and graphs are welcome)

Technology is evolving and becoming more and more commonplace in healthcare. As a result of the pandemic, more people are open to the idea of digital treatment tools, and the NHS has pledged to provide ways to ensure that digital inclusion is accelerated. On-demand healthcare, virtual reality, online treatment sessions, big data, and predictive healthcare are all improving access and outcomes. Online and digital health resources can help with prevention, self-care, shared care and shared decision-making, long-term condition management, and appropriate use of urgent and emergency care.

The challenge for commissioners comes when trying to select which tool is best. There are over 350,000 digital health apps in the market, with an average of 250 new health apps being released every day. The question then becomes, how can commissioners and clinical leads uphold safety standards, whilst putting the best tools in the hands of clinicians and patients?

Historically the NHS has worked to a number of different standards, with various contributions to the Apps Library and a digital assessment questionnaire that had evolved. From a patient-facing perspective that was very complex, but it also raised issues for commissioners who had no common standard to work towards.

In most industries such as banking or travel, there is a baseline standard that everyone adheres to and knows is a minimum – an ISO or equivalent. But healthcare has been lacking. That is why we brought together all the standards so that digital health technologies that are being considered by NHS or social care organizations should be assessed against the Digital Technology Assessment Criteria (DTAC), regardless of procurement route, by the NHS or social care organization that is buying the product.

It defines standards for clinical safety, data protection, cybersecurity, and technical assurance and interrupts and also with a view of accessibility and usability and they are set out now as the absolute baseline that digital health technologies need to meet to operate safely within health and social care. While DTAC is intended to be a ‘one size fits all’ baseline criteria in terms of safety and security, it is intended to be part of procurement, it is not intended to be the complete question set for procurements and should be supplemented with additional specifications including any policy and regulatory requirements.

Because clinical safety isn’t a once and done thing. Having a set of standards does not mean that once that box is ticked an application is fine and available to use for everyone. It’s necessary to continuously uphold clinical standards and safety logs that prove efficacy and excellence. Every interaction, assessment, and engagement will result in new information that needs to be tested against the appropriate criteria. A clinical safety risk profile is dependent on a daily update.

When we look at developing standards we need to look at a systems focus, national programs, and patient-facing criteria. These areas are three very different things but in the past have been looked at together, which has muddied the waters. DTAC applies to all types of digital health technologies, from electronic patient records to public-facing health apps.

By ensuring that the patient needs and healthcare system requirements are front and center of every development, every innovation, every interaction, we can be sure that we are delivering the right tools for truly personalized care. That commitment can’t be a one off. If we’re going to do the right thing, let’s do it repeatedly. Only with a common set of standards that are continually being addressed and revisited, can we safely operate and allow for the innovation and progression that the NHS needs to meet an increasingly complex and varied range of needs in a modern healthcare setting.