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The big reveal happened last week When NHSX launched its Digital Technology Evaluation Standard, With the striking acronym “DTAC” in the style of the NHS. After nearly two years of painful torture among various government health technical problems, this is the result. I can forgive most people for trying to find out what has changed and why it was posted? There is always the possibility that when a government quangos or “independent agency” is created, the policy will be relabeled, rewritten or republished.

If we go back a few years or more before the emergence of the NHSX, the NHS Apps library was co-sponsored by NHS England in 2017 with NHS Digital as part of a citizen-oriented program. It is part of the Digital Transformation Portfolio, which makes it very clear to create a national application library that is approved throughout England at one time for citizens and patients to use. The approval process is through the “Digital Assessment Question”, which is managed by NHS Digital.In the early 70sday On the birthday of the NHS, the Apps library was a huge success.

In the past two years, some things have changed significantly. Not only has the NHSX been created, but it also seems to be confused about what should be included in the NHS Apps library. Libraries are beginning to show some applications that are not patient or citizen-oriented, but are actually for clinicians. It’s not clear how this deviation occurs, but it undoubtedly adds confusion to the developer community-more technology companies want to list their applications-but they find that they can’t usually do it without a clear reason. Arrived.

The end of the NHS Apps library

DTAC responds to the developers and specialists of digital medical technology, apparently wanting to simplify the standard. The evaluation criteria now only cover clinical safety, data protection, technical assurance, interoperability (pass/fail), and (possibly after the fact) usability and accessibility (scoring).

The standard itself is also very interesting, a large part of which has not yet been evaluated, so it is not clear how this information will be used and what impact it will have on decision-making. Compared with the previous standard, the biggest change is that the assessment is now applicable to any product, not only for citizen-oriented applications, but also for almost any product that can be used for health and social care, such as labor applications or clinical decision-making applications program. It seems there will be a “Transition to NHS Apps library’ And certain procurement frameworks (HSSF) also need to be included in the standards, especially those that use national funds.

Burden of proof

However, it seems that there is still a lack of evaluation of the evidence of how well and how well the product works? As we all know, this is difficult, but as we enter the world of digital therapy and combination technology, this becomes more and more important, in which medical technology, applications and medicines will begin to merge together.

No one even knows how to apply the global evidence base to the creation of these new standards, and there are other countries that have taken a different approach, including Belgium and Germany. Belgium uses different levels, so the decision to “approve” a product will not be binary, but will depend more on the expected result, while Germany has set a higher standard, but will approve the decision with the patient-oriented therapeutic The cost of the application is linked.

Mixed estate of DTAC products

NHSX stated that those buying digital medical technology “should also make sure they consider efficacy, impact and evidence”, and it is working with NICE The Evidence Standard Framework of Digital Medical Technology, But currently does not belong to the standard. Compared with those who may have satisfied the later DTAC and those who may have satisfied the later iterations that contain evidence, this has the potential to create a hybrid asset. More importantly, DTAC only applies to new products and contracts within the NHS, and does not retrospectively evaluate solutions-resulting in a mix of products that will be mixed and will not meet the standards of one department or organization for the next department. It seems that there are no regulatory changes to enforce any standards, and the fact that they have not been published as a formal standard that needs to be adopted is likely to result in a lack of exact consistency. bring.

Digital Postal Code Lottery

Inevitably, not all standards can be applied uniformly. For example, the expectations of medical institutions for clinical decision support systems will require different types of assessments than applications that citizens use to access health information or require road signs. By leaving the organization to its own “equipment”, this may cause different hospitals and commissioners to interpret the standards in different ways. We have already seen this when it comes to other purchasing decisions, so it seems impossible to make any difference. Only time will tell whether postal code lottery will appear in digital health technology, but the potential is definitely there. Will we eventually encounter some inequality in digital health? Will there be new applications for the infamous inverse health law? It seems that this is very possible.

Professor Sam Shah is the founder and director of the School of Future Health at Ulster University, the Chief Marketing Officer of Numan and an advisor to Silver Buck.

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