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IntroductionMobile 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.MethodsIn 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”.ResultsFour 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.ConclusionsPatterns 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.

Introduction: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.Methods: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.Results: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.Conclusions: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.

Introduction:The dual mobility concept was invented to prevent postoperative hip dislocation. It has been used for 40 years, but demonstrative data are limited and many designs are available. In France, many implants for hip arthroplasty are reimbursed by the national health insurance system through a generic description that corresponds to a class of products having the same indications and technical features (designs, coatings, types and systems of fixation). Dual mobility cups were one of them until 2017. The ministry decided to set up the assessment of each design of dual mobility cup, marketed in France for their reimbursement.Methods:Manufacturers of these devices submitted medico-technical application dossiers, with technical characteristics and clinical data, to the French National Authority for Health (HAS). HAS has assessed prospectively the actual benefit of these implants.Results:Sixteen companies marketing 42 kinds of dual mobility cups associated with 22, 28 or 32 mm femoral heads and cementless or cemented fixations have submitted dossiers. Their demands were argued on non-specific and specific clinical data. For few implants with non-specific clinical data, arguments to demonstrate the equivalence towards other implants were not accepted for reimbursement. For other implants, the specific data available were only low quality studies. No randomized controlled trials were identified. When the risk/benefit balance was acceptable, the implants were approved for reimbursement and HAS required post-launch data to assess the real-world safety of these implants (i.e. dislocation and long-term survival).Conclusions:All the dual mobility cups marketed in France have been assessed by the French health technology assessment authority. Most of them have been approved for reimbursement, despite of low level of evidence. The brand name inscription enables a specific follow up and the analysis of a post-approval study results in five years.

Introduction:To stay at home, have social interaction, or work, people experiencing urinary retention or uncontrolled urine or feces leakages need specific medical devices (MDs). In France, the MDs used to be covered by the health insurance system if included on a specific list of products and services qualifying for reimbursement. These MDs for urinary and fecal drainage and collection are included under a generic description corresponding to a class of products with the same indications. This coverage modality offered low resistance to unnecessary or wasteful spending. Furthermore, a periodic update of the list is required whereas it has not been done for more than 10 years.Methods:In 2016, Haute Autorité de santé (HAS) assessed the actual clinical benefit of these MDs using a standard health technology assessment method (systematic literature review, opinions of health professionals and patients’ representatives). Manufacturers were asked to provide technical specifications on their MDs.Results:The lack of professional guidelines and well-conducted comparative clinical trials has to be pointed out; among 516 identified publications screened, only seven recommendations, one technological review and one randomized controlled study were selected. Despite this, HAS defined specifications for each generic description, based on users’ experience (patients and caregivers). These included specific indications, minimum technical specifications and, when applicable, conditions of prescribing and use. This assessment took into account individual preferences, the role of the natural carers and the conditions, and opportunities for patients to improve and update their self-care and rehabilitation skills.Conclusions:The HAS assessment of MDs for urinary and fecal drainage and collection provides a cornerstone for the enhancement of the access to the necessary devices for homecare. The expected benefits are an improvement of the quality of life and a reduction of health expenditure due to misuse, complications or hospitalizations.