When legislation gets involved in innovation
But what about the law? Because legislation had to follow. The collection of personal data, reimbursement by the health insurance system and, in the United States, approval by the Food and Drug Administration (FDA), which has not yet validated the HealthKit of the Apple Watch, are all essential steps in the development and widespread use of e-health.
A European directive on medical devices provides a framework for the conformity of these devices... and above all defines the very notion of medical device! This is the 93/42/EEC directive. It has been succeeded by the EU regulation 2017/745.
All these regulations aim to guarantee users:
The reliability of medical equipment
Their safety
The medical effectiveness of this equipment
The respect of their privacy
Its very appearance, and even more so its evolution, both bear witness to the development of e-health. Faced with the rapid development of new health-related technologies, it has been necessary to regulate them in order to protect users and guarantee the rights and freedoms of everyone, both medical professionals and patients.
Despite the boom in e-health and the growing role of technology in the medical field, the French remain wary. In 2018, an IPSOS survey showed that only 29% of French people would accept a diagnosis made by an Artificial Intelligence (AI).
In essence, medicine is the playground of progress. In the space of a century, it has helped to extend our life expectancy by more than 30 years. It has created the vaccine, the pacemaker, the MRI, the transplant, the gene therapy.
Our battlefields have accelerated its progress; they have seen the birth or evolution of radiology, cosmetic surgery, blood transfusion and emergency medicine. Today, does the future of medicine lie in the machine and Artificial Intelligence? driver medical