Meetup-Notes

DTX & HDS

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Table of Contents

Lucine: The first DTx against chronic pain

By Maryne Cotty-Eslous, Founder @ Lucine

DTx

The concept of DTx, which stands for “Digital Therapeutics”, has appeared in 2011 in the United States. It is a subset of digital health and a hybrid of digital, hardware and molecules. DTx can have therapeutic actions without demonstrating a mechanical action on the body, that is without the singetion of a drug.

Medical devices are elements in interaction with the body which have a therapeutic action. This definition changes over time due to alterations made to the legal context. There are about 200 companies in the world doing DTx with a share of 80% of them located in the United States, where the market is valued at 10 billion dollars. Solutions generally focus on chronic diseases with the aim to stay in good shape longer.

Generations of DTx

There are three generations of DTx classified in two types of actions:

The first generation contained Monitoring and additional support to therapy. The former takes measures in real time which could be applied to diabetes for instance.

The second generation was more specific than the first with Intelligent medicine and Cognitive-behavioral therapy or changes in behavior and habits that affect the body in a longer term.

The third generation is composed of the Digital Molecule and new generation Medical devices. The advances in computing, Artificial intelligence and diverse areas of mechanics, science and engineering opened up opportunities. Digital molecules are synthesizable drugs that are fit to a medical profile. This fitness is evaluated by taking measurements and analyzing massive amounts of data, both from corpus and from actual patients to deliver exactly the molecule they need. Since this molecule can have effects superior in terms of strength than morphinics, regulatory compliance is of utmost importance, which renders this domain less accessible to newcomers and helps organizations in place with grants and patents (soon).

Lucine

Lucine belongs to the third generation of DTx, specifically in the Digital Molecule wave. They chose to focus on mental illnesses and chronic pain. Pain causes cases of addiction and death to several thousand per year. In France, 4 people accidentally die each week by overdosing on painkillers.

Chronic pain affects a fourth of the world population. Only 3% receives medical support! 94% of individuals over 75 suffer from chronic pain. In France, doctors are not well trained to identify and handle pain cases and pain treatment centers are few.

No new molecule has been found in 50 years to fight back but thanks to the new value found in clinical studies and trials, neuro-scientific data and emergence of competition, the market is on the move again and new solutions may arrive soon.

Hosting health data

By Emmanuel Meyrieux, Compliance project manager @ OVH Healthcare

Any health data hosting provider must comply with stringent requirements such as:

Improving someone’s health requires following ISO 13485. In the same vein, ISO 27001 defines ground rules for healthcare’s HDS certification in France:

This legal framework, unlike the GDPR, is not uniformly applied across Europe. The GDPR changed the sensitive data market and possibly even the way financial institutions handle our information. It has been published in April 2018 and applied since June of that year. The reference documents for GDPR are not clear enough, which caused regulatory issues, including and especially with FAANG-type companies.

As a consequence, this guarantees a minimal level of security regarding health data hosting and allows to define ground rules for certifications. There is no official way to determine the limit between what is considered sensitive data or not though, out of case-law.