Ukraine’s Health Ministry Drafts Comprehensive Law to Regulate AI in Medicine

Ukraine's Health Ministry is crafting extensive legislation to govern the utilization of artificial intelligence (AI) in medicine as the technology permeates more sectors, including hospitals and the battlefield. Health Minister Viktor Liashko announced on November 13 the upcoming presentation of the draft for public scrutiny, though he did not specify a deadline.

The bill aims to enable broader AI application while safeguarding patient rights and safety. Presently, Ukraine lacks comprehensive regulations governing AI systems in healthcare, leaving developers and medical facilities uncertain about scaling promising solutions. The proposed law would establish clear guidelines for developing and employing medical AI systems, categorize them by risk level, and mandate adherence to safety, transparency, and accountability standards for both providers and users.

Liashko emphasized that patients' medical data must remain protected, and AI must be overseen by qualified medical professionals. A recent Health Ministry survey under Ukraine's digital development strategy WINWIN 2030 revealed that 80.5% of over 7,000 medical professionals surveyed use AI tools, with 21.6% using them regularly and 58.9% occasionally.

The majority of respondents, 65.7%, support AI in healthcare, with the highest enthusiasm from the private sector. Doctors most desire AI assistance in accessing clinical guidelines (57.4%) and regulatory documents (54.1%), while a third hopes to leverage it for differential diagnosis or workflow planning, and 31% for drafting medical records.

Respondents stressed the importance of AI tools basing their recommendations on verified official sources and displaying how they arrived at their suggestions. The primary concern expressed was system errors. When asked about their perspective on AI in medicine, 67.5% of 300 surveyed patients supported its use. Most favored explanations in plain language for diagnoses and test results and assistance in locating a doctor, rather than replacement.

A majority would accept AI as a supportive tool, provided the final decision rested with the doctor. Surprisingly, the survey also included 39 businesses and organizations, such as software developers, medical device manufacturers, and pharmaceutical firms. The development of AI-supported ground robotic systems and unmanned vehicles for dangerous frontline missions is another area where Ukraine is increasingly relying on AI.

Over 300 patients surveyed backed AI's role in medicine, preferring explanations in simple language and help in locating a doctor.