The organizational impact (OI) of new technologies is becoming a major driver for our healthcare systems and for modernizing the care pathway for the benefit of users and professionals. Some technologies give rise to a reorganization of the healthcare system, particularly in the case of connected medical devices.

The Medical Device Committee at Haute Autorité de Santé (HAS) appraises medical devices (MD) in view of their reimbursement by the French health insurance scheme. The Committee’s evaluation criteria take account of the therapeutic benefit of the MD and its public health benefit. OI-related aspects are frequently claimed by health technology developers (HTD) in their MD submission dossiers. However, this aspect is rarely documented. Therefore, guidance explaining how HTD should support and structure any claim of an OI was needed.

This work was based on the HAS OI Map for Health Technology Assessment published in 2020, the analyses of specific HAS opinions, hearings with concerned stakeholders (HTD, service providers and patients), and a committee meeting focused on OI.

The HTD guide for MD submission was updated with guidance to support OI claims. For each claimed OI, the HTD should identify the criterion corresponding to the most relevant OI, the indicator to describe each selected criterion, the stakeholders concerned, and the data to be provided. The choice of method is according to the OI: if the indicator is measurable, data from validated measurement tools are expected. If not, especially in cases where the use of the MD requires a specific organization before its deployment, the absence of data must be justified and a detailed impact analysis is necessary. In this case, the development plan for the demonstration of the OI is needed.

With this updated guide for HTDs, claimed OI dimension shall be better supported in future MD dossiers submitted to HAS in view of their reimbursement in France.

Mobile health systems (MHS) are one of the more spreading technologies in the field of medicine. However, identification of useful MHS is rather challenging. Few of them are, or could be, connected medical devices (cMD). Like other medical devices, cMD must be assessed to validate claimed benefits for reimbursement purposes. Clinical added value demonstration is a major criterion used to satisfy administrative requirements. With the increase of clinical studies that are including MHS, study registries can be used for insight into the type of evidence expected to become available in the near future.

In 2018, the French National Authority for Health (HAS) performed a review of registered MHS clinical study designs. The Clinicaltrials.gov database was consulted for all studies indexed with the terms “mHealth” and “mobile health” for the search fields “study title”, “conditions” and “interventions”.

Four hundred and fifteen clinical studies were registered. Three hundred and eighty studies were interventional with most comprised of a randomized study design (75 percent). Fifteen had a crossover design. Only few observational studies (n = 35) were registered. These mainly concerned (59 percent) patient use of an app on a smartphone without any other device.

Patterns of clinical studies were not found to significantly differ between MHS and other medical devices. Most of the clinical studies were randomized and specific criteria to assess MHS could easily be identified. However, specific methodologies for clinical development are not used in practice for cMD health technology assessment. In the absence of validated and specific methodology for clinical development, current methods that are being used in these ongoing studies will nonetheless be generating evidence for the upcoming years.

More and more software programs, including those with medical device status, are coming into the market that aim to facilitate management of diabetic patients. In France, their coverage requires a positive opinion from the French National Health Agency (HAS) dedicated committee. To understand the utility of these products for patients, real-life experiments are in progress. Since the evaluation principles are similar for all medical devices, it was important to find out with this first connected software if specific methods or evaluation criteria are necessary.

After obtaining CE marking, the manufacturer submitted a dossier to HAS outlining the clinical data and technical performance of the software. HAS assessed the dossier and the opinion of stakeholders (i.e. professionals and patient associations) in order to determine the actual clinical benefit of this software. At the same time, HAS set technical features in particular to secure patient data and limit access to only those involved in telemonitoring. Terms of prescription and use of this connected software had also been defined.

Two feasibility studies and one randomized controlled trial were analyzed. Specific clinical data demonstrated that the risk-benefit balance was positive in type 1 diabetic patients.

In addition to the need to keep personal data confidential and to integrate the technology in the organization of healthcare, this assessment shows that randomized clinical trials are feasible and necessary to demonstrate the clinical benefit of connected software; however, specificities exist regarding data collection methods and the scope of healthcare organization that should be taken into account. A specific guide to connected medical devices for industry has been developed by HAS to help them build their application dossier for reimbursement. The second step for HAS is to develop guidelines on the specificities of the assessment of these connected devices.