DiGA Goes Class IIb, DiGA Wearables, Oura’s Opportunity

Starting with some “old” news, in March BfArM started reimbursing Class IIb DiGA apps, from reuschlaw:

Prior to the Digital Act, DiGAs had been limited to the lower risk classes (I and IIa). This has now also been extended to the higher risk class IIb within the meaning of Art. 51 in conjunction with Annex VIII of Regulation (EU) 2017/745, so that the possibility of inclusion into the catalogue of reimbursable DiGAs now applies to a significantly wider range of products. However, for DiGAs in risk class IIb stricter requirements apply for inclusion into the list of reimbursable products maintained by the BfArM (Federal Institute for Drugs and Medical Devices). Digital health applications in risk class IIb must provide evidence of a medical benefit in addition to the relevant evidence of a positive healthcare effect (Section 139e (2) sentence 4 SGB V). This requires the submission of a prospective comparative study (Section 11a (1)  DiGAV). A mere improvement of a patient-relevant structure or procedure is not sufficient for the inclusion of risk class llb DiGAs into the catalogue of reimbursable products.

What Class IIb allows for is continuous remote monitoring (telemonitoring) of treatment progress and it is particularly interesting in the case of chronic conditions. But tracking vitals is not enough, the new tele-DiGAs need to also provide the patients with personalised recommendations on what to do, from BfArM (translated):

The goal of a digital health application (DiGA) must be to support patients, for example, in the treatment of an illness. Simply recording and graphically displaying side effects and vital signs is insufficient. Liver cancer patients, for instance, should receive direct recommendations or guidance on how to manage a side effect or a vital sign outside the normal range. This information can also be made available to the treating physician. Therefore, this type of telemonitoring will likely only be possible in the context of risk class IIb.

As I noted in Data Value Chain, AI vs The Value of Human Judgement, there are roughly speaking two ways to capture clinical data in the hospital: a human can type it or a diagnostic device can capture it with its sensors. What tele-DiGA did was expand the business case for using such devices beyond the hospital setting. Wearable devices can now become the patient’s clinical companion throughout their life, helping them manage symptoms and adjust treatment as required.

57% of Oura’s US customers are indeed people with at least one chronic condition, trying to manage their health. Oura is not a medical device yet, but they can easily find the budget for it and that in combination with already being the trusted health-companion to millions of chronic patients is one explosive combination.

Does that mean we are going to see a wave of DiGA-wearables soon? VCs seem to be skeptical, quoting high costs and low adoption rates. But while costs will continue to be high, perhaps adoption is slowly coming to a tipping point.