In the field of health innovation, the HAS:

• Evaluates health technologies for reimbursability
• Evaluates the eligibility of requests for innovation packages (special reimbursement system for innovative technologies).

In the field of business software for healthcare professionals, the HAS:

• Approves databases for drugs, medical devices and associated services (BdMs) on the basis of a quality charter
• Establishes the procedure and certification standards for prescription assistance software (PAS) and dispensing assistance software (DAS): Outpatient PASs, hospital PASs, pharmacy DASs and internal use pharmacy DASs
• Develops medical decision support systems: decision support systems (DSS) indexed by drug, and data sets of best practices
• Structure of coordination document models that can be integrated into business software, exchanged by secure health messaging or shared in the Shared Medical Record (DMP): Medical summary section (VSM), personalised health plan (PPS), document for discharge from hospital after a stay longer than 24 hours (DSH), emergency transfer document (DLU), personalised health coordination plan (PPCS).

In the field of telehealth, the HAS:

• Promotes the proper use and quality of telemedicine (teleconsultation, teleexpertise and teleimaging) and telecare activities: Eligibility criteria, recommendations for implementation, patient information sheets, rapid responses for COVID-19, "patient tracer" method for evaluating professional practices
• Develops tools to support the deployment of telemedicine in France: Telemedicine efficiency, security grid for a telemedicine project
• Evaluates telemedicine trials for wider roll-out

In the field of telehealth, the HAS:

• Provides manufacturers and evaluators with a best practices standard for assessing the quality of mobile health apps and connected objects
• Develops the medical content quality directory listing digital services in Health Data Personal Storage (ENS), a service platform for citizens, and in the service package (BS), a service platform for health professionals.

I have a project, how can contacting the HAS be of use to me?

In the field of health innovation, you can contact the HAS to:

• Consult the standards and best practice guides that concern you
• Anticipate how to access reimbursement for your solution

The HAS can assist you at certain stages of your project. Our subject-specific information meetings may be useful to you. Practical and methodological guides, as well as standards to help you in your future application for reimbursement or to build your clinical development plan are available on our website.

We are not able to assist you step-by-step in your project, but personalised guidance is possible through meetings devoted to your solution.

In the fields of business software, telehealth and mobile health, the HAS can support you by answering your questions e-mailed to sa3p@has-sante.fr

• If you are a drug database publisher, create software for managing a medical practice or pharmacy in an outpatient or hospital setting or software for writing or dispensing a medical prescription, or if you are considering applying for the certification of PAS or DAS software, the HAS can answer your questions on what steps must to be taken (approval procedure and certification procedure) and on the content of the certification standards
• If you are offering a digital telemedicine service (teleconsultation, remote interpretation of imaging exams, etc.), the HAS guides will help you understand the best practices to implement
• If you are carrying out a telemedicine project, the security grid helps you to identify and minimise the specific risks of your project
• If you are a manufacturer (app designer, start-up, etc.) or an evaluator (evaluation structures, consumer associations or medical science societies) the best practice guidelines for mobile health apps and connected objects will enlighten you on the best practices to take into account for a safe, quality design. This guide aims to promote the use of and build trust in apps and connected objects

At what stage of my project should I contact them?

On a practical level, the HAS can help you before you submit your application for reimbursement. There are two types of meetings available for technologies that count as medical devices or involve the creation of a new care procedure, depending on how far along you are in your development:

• Early meetings if you are planning a clinical study and would like to discuss it with the HAS teams and their experts. The main objective of these meetings is to discuss the questions you have regarding the methodology of the clinical study you are considering. This type of discussion can be useful before the implementation of your study. It is therefore at this point, as soon as your planned protocol has been crafted, that you can contact us.
• Or pre-filing meetings: these meetings are set up specifically for medical devices in order to assist manufacturers with the technical and regulatory aspects of setting up or finalising their application (scope of the LPPR list of reimbursable products and services, content of the application in particular).

If you have any questions about business software certification, telehealth and mobile health, you can e-mail your request to sa3p@has-sante.fr