The evaluation of digital medical devices (DMDs) in France is now structured around the LATM – List of Medical Telemonitoring Activities. This reimbursement pathway, established by the 2022 Social Security Financing Act and detailed by decree n° 2022-1767, has become the reference route for securing reimbursement of telemonitoring solutions by the national health insurance system.
However, inclusion on the LATM comes with demanding clinical requirements. The CNEDiMTS (National Commission for the Evaluation of Medical Devices and Health Technologies), in charge of issuing scientific opinions, does not limit its evaluation to the DMD itself. It assesses the inseparable combination of the digital device and the associated medical supervision.
Demonstrating added value versus the comparator
Listing on the LATM is only possible if the telemonitoring activity demonstrates a clinical or organizational benefit compared to either:
- Conventional medical follow-up, or
- An existing telemonitoring activity already listed for the same indication.
This makes the choice of comparator a critical strategic element.
- Case 1: If no telemonitoring activity exists for the indication, the comparison must be made against standard medical care.
- Case 2: If an activity is already listed, the new entrant must prove clinical or organizational superiority, or at least a robust equivalence.
Example from HAS: In oncology, a company submitted comparative data versus conventional follow-up. However, since another solution had been listed in the meantime, CNEDiMTS required an additional comparison against the newly listed reference, both technically and organizationally.
Key criteria for clinical evaluation
1. Clinical improvement in patient health
The CNEDiMTS expects strong evidence showing improved outcomes compared to the chosen comparator, such as:
- Fewer complications or serious adverse events,
- Reduced hospitalizations or emergency visits,
- Better survival rates or improved quality of life.
Example: In oncology, the commission concluded that telemonitoring preserved quality of life and reduced emergency admissions, which supported a favorable opinion.
2. Significant organizational gain
Beyond direct clinical outcomes, measurable organizational impact can justify LATM listing, for example:
- Optimized care pathways,
- Improved coordination among healthcare professionals,
- Reduced workload and associated healthcare costs.
Example: For heart failure, the first evaluation of telemonitoring recognized organizational benefits even though clinical evidence was limited. A post-listing study was then required to confirm the clinical benefit.
3. Public health benefit
The commission can also value broader impacts such as:
- Reduced mortality or morbidity at the national level,
- Alignment with national public health priorities,
- Addressing an unmet medical need.
Clinical studies: level of evidence required
The CNEDiMTS prioritizes randomized controlled trials (RCTs) but accepts alternative designs when randomization is not feasible. In such cases, the company must justify why RCTs are impossible and propose strong alternative methodologies.
Accepted endpoints include:
- Primary endpoints: clinical improvement (survival, hospitalization rates, quality of life) or measurable organizational impact,
- Intermediate or surrogate endpoints: relative dose intensity, reduction of severe toxicities,
- Patient-centered outcomes (PROMs/PROs): quality of life reported directly by patients.
Example: In metastatic cancer, a study using PROs showed improved quality of life and fewer hospitalizations. These data were considered acceptable by CNEDiMTS.
Frequent causes of rejection
The HAS has identified several recurring mistakes leading to rejection of LATM applications:
- Lack of data specific to the technology being assessed, relying only on extrapolation from other solutions,
- Availability of technical data without proof of clinical impact,
- Claims of superiority not backed by strong comparative evidence,
- Studies conducted on earlier versions of the DMD, not transposable to the version under review.
Example: In ophthalmology, a DMD showed good technical performance but no demonstrated impact on patient management. CNEDiMTS concluded that expected clinical benefit was not established.
Renewal and post-listing follow-up
LATM inclusion is granted for a maximum of five years. For renewal, manufacturers must provide:
- Data from post-listing studies requested by the commission,
- Real-world usage indicators,
- New clinical or safety data (including materiovigilance).
Example: In oncology, CNEDiMTS required a three-year post-listing study to confirm clinical and organizational benefits across different patient subgroups.
BluePharm: supporting LATM success
In this demanding environment, BluePharm provides tailored expertise through:
- Strong experience in clinical trial methodology,
- Support in structuring medico-technical dossiers,
- Integration of clinical, organizational, and health-economic perspectives,
- Anticipation of common pitfalls identified by CNEDiMTS thanks to active regulatory monitoring.
For companies, the outcome of an LATM dossier directly determines reimbursement eligibility. BluePharm positions itself as a key partner to help innovative health technologies succeed in improving patient care.
Conclusion: LATM as a decisive gateway for digital health reimbursement
The LATM pathway represents a turning point for digital medical devices in France. By setting high clinical evaluation requirements, it ensures that only solutions with a proven impact on patient outcomes, organizational efficiency, or public health gain access to national reimbursement.
For innovators, this means building robust clinical and organizational evidence, carefully selecting comparators, and anticipating post-listing requirements. With the right expertise, LATM becomes not just a regulatory hurdle, but a strategic opportunity to demonstrate value and secure sustainable market access.
Useful links
- HAS – Specificities of clinical evaluation for connected medical devices (2019)
- HAS – Real-world studies for evaluating drugs and medical devices (2021)
- HAS – Mapping organizational impacts (2020)
- Basch et al., JCO 2016 – Patient-reported outcomes in oncology
- Article PECAN fast-track pathway: evaluating digital medical devices
