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The use of artificial intelligence in medical devices already involves compliance with specific legal requirements to protect patient health.
In the coming years, upcoming legislation (such as the AI Act) may increase the number of applicable regulatory requirements, a topic of great debate (and concern) within the medical device industry.
Artificial intelligence is revolutionizing the life science industry by offering technology solutions that can significantly impact new product development, patient care, and the efficiency and sustainability of national healthcare systems. But let’s cover the potential legal challenges.
Is artificial intelligence-based software a medical device?
From a regulatory perspective, products containing AI-based software may be considered medical devices depending on the specific intended use identified by the manufacturer.
In general, only software with a medical purpose, for example, is used to diagnose, monitor, or prevent a disease-qualifies as a medical device. In contrast, software with a “generic” and non-medical-diagnostic purpose does not fall into that category, even if designed for use in a healthcare setting.
Consider, for example, software that collects, archives, stores, or transmits data acquired through specific electromedical equipment: such products create a searchable database in the provision of health care services, but because they lack a specific medical purpose, they do generally not qualify as medical devices.
The classification of software as a medical device is of particular importance because it involves the application of specific requirements to ensure the protection of the health of patients and users.
The benefits of artificial intelligence in medical devices
There is no question that, in recent years, the medical device industry has seen an exponential increase in products that contain AI software.
Using such systems and solutions makes it possible to improve the accuracy of diagnoses, reduce human error in identifying pathologies more accurately, and offer therapeutic solutions that can increase the chances of recovery, positively impacting the effectiveness of treatments.
Improved efficiency of available tools translates into reduced access time and duration of care, benefiting patients and health systems.
Examples of medical devices leveraging artificial intelligence
From software that can assist physicians in diagnosing a condition to software that suggests personalized treatment options based on specific data reported to the patient, such as genetic profiling, numerous examples of medical devices take advantage of artificial intelligence.
Still, AI has found numerous applications in radiology (where various software currently on the market analyzes image data and detects abnormalities) and in surgery, where surgeons are increasingly being assisted by sophisticated devices to perform the most delicate surgeries.
However, it cannot be true that medical devices that take advantage of AI must necessarily be complex products accessible only to healthcare professionals. On the contrary, several solutions have been designed specifically to be made available to patients in the daily management and monitoring of numerous diseases.
A good example is products intended for patients with diabetes: they can continuously monitor blood sugar levels and automatically adjust insulin administration.
Impact of the AI Act on medical devices
While from a regulatory perspective, AI software with medical purposes is considered a medical device, mention should be made of a regulatory change that will affect the entire industry.
Indeed, the European Union has recently been moving toward adopting the AI Act, which will significantly impact medical devices that contain AI software. Indeed, under the provisions of the current AI Act proposal, such products could be subject to a dual regulatory regime of medical devices and products containing AI, with a considerable increase in regulatory obligations on those involved in the supply chain.
In conclusion, using AI in medical devices already entails compliance with specific requirements to protect patient health. In the coming years, upcoming regulations may increase the number of applicable regulatory requirements.
The issue is the subject of much debate within the industry, where numerous voices are stressing the importance of avoiding the multiplication of obligations on those involved in the supply chain, despite a rapidly evolving regulatory framework that, to date, leaves room for some interpretative uncertainties, the use of AI systems undoubtedly offers significant opportunities to improve patient health and the efficiency of healthcare systems. Developments in technological innovation and the regulatory framework in the life science sector are, therefore, awaited with great interest.
On a similar issue, you can read the article “AI Act agreed, what you need to know on the upcoming EU artificial intelligence law.”
Authors: Nicola Landolfi and Carlotta Busani of DLA Piper
