French Digital Health Agency certification

11 December 2023
The CareLine Platform has been certified by the French Digital Health Agency (Agence du Numérique en Santé – ANS) to comply with the interoperability and security common specifications for digital medical devices and the French HTA (Haute Autorité de Santé – HAS) common specifications for “heart failure remote monitoring”. Therefore, it has been included in the list of certified solutions published by ANS. This certification ensures compliance with regulatory requirements for the implementation of remote monitoring to the benefit of heart failure patients under care.
To that effect, the CareLine Platform integrates the most recent technologies of the core services included in the national the digital health doctrine, including the Pro Santé Connect authentification, synchronization with the National HCP Directory through a FHIR API or certificate-based authentication to interrogate the INSi service. With this certification, CareLine Solutions demonstrates its commitment to healthcare professionals in supporting innovative medical practices. The CareLine Platform certification by ANS also enables its coverage by French Health Insurance (Assurance Maladie) with a dedicated code for remote monitoring systems. This dedicated code has been included in the list provided for in Article L. 162-51 of the Social Security Code. Learn more on ANS website.

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CareLine Solutions: for 100% customizable remote monitoring of your heart failure patients

CareLine Solutions: for 100% customizable remote monitoring of your heart failure patients

In the context of remote monitoring of heart failure, Decree No. 2022-1767 of December 30, 2022, relating to the coverage and reimbursement of remote medical monitoring activities, stipulates that the only mandatory parameter to be monitored daily is weight.
CareLine Solutions has chosen to go well beyond this minimum requirement by offering comprehensive, personalized medical care focused on clinical expertise and care coordination.

CE-Mark

CE-Mark

The Alert Module of the CareLine HF-Platform is a Class IIa medical device software performing automated multiparametric analyses of patients’ physiological parameters using customizable algorithms and generating related alerts to support remote management of chronic heart failure with the CareLine-HF Platform. It is intended to be used by healthcare professionals providing care to chronic heart failure patients under the supervision of a heart failure specialist.

Remote management of heart failure is not intended to ensure continuous monitoring of patients or provide them with emergency care. Patients should be informed and educated accordingly.

Read carefully the healthcare professional instructions for use.
The CareLine HF-Platform is on the French Assurance Maladie’s reimbursement list for remote medical monitoring activities mentioned by article L. 162-52 of the French Social Security Code. Coverage is conditional to the activities being operated by a declared remote monitoring operator and to the patient following a therapeutic educational program.

Remote management of worsening heart failure

Remote management of worsening heart failure

A remote management strategy based on multiparametric remote monitoring performed by an integrated medical team using the CareLine platform is likely to reduce hospitalizations for decompensated heart failure.

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