diSergio Pillon
The key principles to be guaranteed, according to the first national law: protection of personal data, fairness, right to information for citizens, accessibility, autonomy, security and social inclusion. AI cannot replace the doctor
It is said in the industrial world that America innovates, China copies and Europe regulates. This cliché seems to be fully confirmed even when talking about artificial intelligence (AI). In September 2022 the US government through the GAO (US Government Accountability Office), the US government department that deals with accountability (from oxford dictionary; responsibility, reliability) together with the National Library of Medicine published a study on employment and challenges of artificial intelligence in health, from which the activities of large US companies began, up to President Biden’s Executive Order, which established the first rules for the development of AI.
L’AI European Act
Europe has managed to regulate, with a very detailed AI ACT of more than 430 pages, but it will not enter the legislation of the member countries for two years. It is necessary to answer many doubts from today in order to encourage the use of a tool now considered mature in many fields, primarily for health.
The draft bill
With this philosophy he arrives in Italy «Outline of the bill containing provisions and delegation to the government regarding artificial intelligence» published April 23, 2024. Healthcare begins in Article 7: “Use of artificial intelligence in healthcare and disability.” Disability is present from the beginning, we talk not only about care, not only about the National Health Service but about social and health services and the use of AI for the realization of the life project of people with disabilities.
The key principles that must be guaranteed are: the protection of personal data, fairness, the right to information for the citizen, accessibility, autonomy, security and social inclusion. AI can never replace the clinician: «Artificial intelligence systems in the healthcare sector provide support in the processes of prevention, diagnosis, treatment and therapeutic choice, without prejudice to the decision, which is always left to the medical profession». Finally, the protection of citizens through the obligation to continuously update and verify applications
Electronic health record
A final key point, the electronic health record, where AI
is essential. We doctors often have too much data, patients arrive with bags full of analyzes and tests, reports, files in folders. The luckiest of us have young assistants who review the folders, but this is reserved for very few VIPs, both doctors and patients.
The AI in the electronic health record can make an evaluation of the documents: it is not treated with the data, but with the story that we can create using the information. The data are of little use to the doctor if taken all together, they are useful if they can be integrated to meet the needs of the doctor and the patient in that specific moment, in that meeting and to plan the future diagnostic-therapeutic path. This is why AI in health is not only central, it is indispensable.
The National Platform
A solution was also needed to the problems that had arisen after the request for clarification on the tender for the AI for local medicine, a request from the Privacy Guarantor which had effectively forced Agenas (national agency to suspend phase III of the creation of the Platform of Artificial Intelligence to support primary healthcare and the topic is addressed in the law.
It was necessary to quickly fill legislative gaps that could have slowed down the use of AI which must be rapid, so as not to lose many opportunities also for Italian SMEs (Small Medium Enterprises), but regulated. The European Union’s AI ACT is comprehensive and complex, but requires a long process. We need to move quickly, guaranteeing citizens’ rights and protecting companies that invest to develop projects. In health, the result seems to have been achieved.
*Vice president and head of institutional relations AiSDeT, Italian association of digital health and telemedicine
April 30, 2024 (modified April 30, 2024 | 12:25)
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