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PECAN App Development Process

Our roadmap to success

Facilitating easy access of digital health solutions is a tough job. With apt regulatory procedures in place, PECAN can be eligible for early care with early reimbursement by health insurers for a year even for risk classes IIb and III, while still gathering clinical evidence.

It demands a thorough understanding of action items, contacting relevant authorities, guidelines for a successful process, relevant documentation and valuable resources.

We, as your reliable digital health technologies partner, can help you in traversing through all major phases of the project, including DMD approval and entry into relevant registers - LATM (DMD for health monitoring) and LPPR (DMD for therapeutic purposes).

Ideation, Analysis and Feasibility

It all commences with your aspiration of having a digital medical device (PECAN) in France. With a client-centered focus, we understand the idea and check for its feasibility in terms of technicalities and functionalities.

Our domain experts extract the possible opportunities that could be coming along the way after a thorough analysis of the idea and its futuristic insight.

Commencement and Project planning

Once the idea is approved, we, in alignment with your project and legal requirements, prepare a detailed plan for creating the design, development and testing roadmap.

As a proficient IT partner, our modern-day project management strategies clubbed with our expertise in the healthcare segment weave a robust and flexible plan in action.

UI/UX design and Prototyping

Our creative design taskforce comes up with an innovative application design, user interface and experience that offers the perfect look and feel of the application bundled with its working style.

As needed, we create a prototype or build a proof of concept to offer a primary visualization and get user feedback at an early stage.

Agile development & Testing

With a close observation on the regulations marked by the French authorities, our health app development team creates a software application that is reliable and effective; could be either mobile-based or web-based.

Our programming methodologies follows the best industry standards that are applicable for digital healthcare, along with the fundamental agile principles. We also produce relevant images, texts, videos and other graphic components.

Implementation & Registration

Once we create a digital health application, we guide your app through obtaining the European CE mark. We help in validation of solution by the Digital Health Agency after which the final approval from CNEDiMTS (National Commission for the Evaluation of Medical Devices and Technologies) is sought.

Once published, the application will be registered into the list of reimbursed medical services and products, under either of the following categories - digital health solutions or digital therapeutics (DTx) or remote health monitoring systems.

Post launch support & Promotion

We will be happy to help and support you with our technical and domain expertise on a continuous basis. Our support, software update and maintenance activities ensure a smooth functioning of your digital health application.

We also offer expert marketing and promotional consultation for your app to reach out far and wide through pioneering campaigns and digital marketing. After the initial one-year period, we assist in obtaining a permanent reimbursement with due delivery of clinical evidence.

Do you wish to go through details about PECAN and its implementation?

Here is a good and authentic read:
Important Information on PECAN - Guide Published by GNIUS

Pre-requisites for PECAN apps

To get successful registration

For the solution to get registered in the list of medical services and products, there are certain fundamental requirements that needs adherence and we can help you achieve that. Here are those necessities:

For a solution to be reimbursed under PECAN, it must

  • have a European CE certification marking as a medical device under Medical Devices Regulation (MDR)
  • showcase an innovative clinical benefit for the patient or organizational enhancement for the healthcare segment
  • adhere to the safety, security and interoperability standards set by the French Digital Health Agency
  • comply with the national and international data protection law
  • offer clinical evidence as it moves onto getting permanent reimbursement status
  • possess technical certification on GDPR compliant and cybersecurity norms

Are you skeptical about all that you have to manage as you create your PECAN solution - Application to the French Ministry of Health, Basic Evaluation and Temporary Reimbursement, Application for Permanency, Evaluation for Positive Effect, Availing Permanent Reimbursement?

Worry Not! As your one-stop healthcare app development company, we are here to help, at each of these junctions.
Let us chalk out a plan leading to a successful PECAN app!

Frequently Asked Questions

What is PECAN and what is its significance?
PECAN stands for 'Prise en Charge Anticipée Numerique' in French and interprets as 'Early Access to Reimbursement for Digital Medical Devices'. It is the French corresponding of DiGA - the German fast track digital health application approval. It facilitates digital health applications, digital therapeutics (DTx) and telemonitoring solutions to be reimbursed by the French authorities.
What is the difference between DiGA and PECAN?
Though both focus on digital healthcare solutions, DiGA supports medical devices of lower risk classes - I and IIa only, whereas, PECAN supports all risk classes - I, IIa, IIb and III. While DiGA emphasizes on completed clinical assessment indicating positive outcome, PECAN can be sought even if the clinical study is still going on. DiGA is only for digital therapeutics while PECAN is for the same and telemonitoring solutions too.
Is it assumed that if you have DiGA approval, you can easily get PECAN approval in France?
Though it comes up as an advantage for seeking PECAN sanction, having DiGA does not only suffice. There are other regulatory compliances and consents that have be to sought from authorized French bodies in order to attain PECAN approval.
Who can apply for PECAN?
Any Digital Medical Device in the French territory, that is seeking temporary health insurance coverage and focusses on either therapeutics or remote monitoring can apply for PECAN. Of course, there are other pre-requisites that must be adhered to like clinical advantage, valid CE mark, security aspects etc.
What could be the possible implementation challenges while going in for PECAN?
As you go in for a PECAN solution, there is a need to have an insightful knowledge about the French rules and regulation. One must also understand the complicated needs with respect to GDPR compliance, security concerns and interoperability standards. There is a lot of documentation involved as a part of a lengthy procedure.
What categories of health apps get covered under PECAN?
PECAN takes into consideration two types of health solutions – Digital Therapeutics and remote health monitoring systems.
What are the two different registers involved in PECAN?
Once the digital health solution gets approved by PECAN, the application must be filed for standard registration in one of the two registers: LATM (within a period of 9 months) includes all digital medical devices that monitor health information and LPPR (within a period of 6 months) includes all DMD with therapeutic usage.

LATM refers to List of Medical Telemonitoring Activities whereas LPPR refers to List of Reimbursable Products and Services.
Is the DiGA and PECAN model being implemented in other countries apart from Germany and France?
It all started with Germany and then France but there is no looking back. It has started gaining traction in places like Austria, Belgium, Italy etc.
How do you witness the future of PECAN in France?
France has been investing in the digital transformation of their healthcare system, on an increasing spree. The future shall witness creation and successful implementation of digital health solutions under the PECAN.
How much does the temporary reimbursement last for a PECAN?
Once your PECAN is approved, the temporary reimbursement lasts for 12 months, after which it must be permanently reimbursed based on the type of register.

Avail advance care in health segment with our end-to-end PECAN services

Avail advance care in health segment with our end-to-end PECAN development services

We ensure insightful communication and collaboration with relevant French PECAN experts for getting your digital healthcare solution approved and listed. We collaborate with reliable French associates to come up with a stringent and robust reimbursement mechanism. With us, rest assured, you are bound to enjoy a seamless experience with your PECAN solution.

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