Middle East war crisis accelerate regulatory flexibility

MOHW considers easing essential medicine regulations ahead of telemedicine legalization

Expanding beyond medical product delivery for rare disease patients and primary care innovation programs

Amid the government’s push to address gaps in regional, essential, and public healthcare, the prolonged Middle East conflict is accelerating efforts to ease regulatory barriers through AI and telemedicine.

The Ministry of Health and Welfare plans to take the lead in advancing regulatory reforms to fully utilize new medical technologies, such as AI and telemedicine, in order to strengthen regional, essential, and public healthcare and respond to the crisis caused by the war in the Middle East.

The Ministry has already begun implementing measures to directly deliver medical supplies, such as syringes, IV sets, and medications, via telemedicine to patients with rare and intractable diseases, who are facing even greater difficulties in securing medical supplies due to the war in the Middle East.

On the 9th, the Ministry announced plans to explore regulatory rationalization measures that would allow for the aggressive use of AI and telemedicine as part of efforts to strengthen regional, essential, and public healthcare.

Currently, the Ministry is in the final stages of administrative procedures to establish a Regional, Essential, and Public Healthcare Division (hereinafter referred to as the “REPH Division”). Following consultations with the Ministry of the Interior and Safety, a consensus has been reached on the necessity of establishing the division, and efforts to secure the necessary personnel and budget are currently underway.

Based on the establishment of the REPH Division and organizational restructuring, the Ministry of Health and Welfare intends to identify additional measures to integrate new medical technologies into regional, essential, and public healthcare.

A prime example is the Primary Care Innovation Pilot Project, an initiative where local governments and regional primary care institutions design policies to proactively reform regional, essential, and public healthcare and submit them to the Ministry of Health and Welfare. Upon review, the Ministry provides policy and budgetary support.

In particular, as the government is now able to respond to public health needs through dedicated public health officials based on the supplementary budget passed by the National Assembly, it will identify additional cases of regulatory exemptions for AI and telemedicine.

An example of such a regulatory exemption is the collaboration between the Ministry of Health and Welfare and the telemedicine platform SolDoc to allow the direct delivery of medical supplies via telemedicine, aimed at minimizing the impact on patients with rare and intractable diseases caused by the fallout from the Middle East war.

The Ministry of Health and Welfare has already begun administering the direct delivery of medical supplies to patients with rare diseases using a qualification verification system linked to SolDoc and medical institutions.

These supplies, which include syringes, IV sets, suction tips, suction catheters, sterile saline, and disinfectant swabs, are essential for the home treatment of patients with rare diseases. The Ministry plans to gradually expand this in stages to include the delivery of medications as needed.

With the passage of the revised Medical Service Act by the National Assembly, telemedicine will be fully institutionalized starting this December. The main provisions of the law include broadly permitting telemedicine for patients with rare diseases and allowing hospitals and higher-level medical institutions to provide telemedicine services under certain restrictions.

The Ministry of Health and Welfare plans to expand telemedicine services based on regional, essential, and public healthcare until the Telemedicine Act takes effect.

A Ministry official explained, “Since addressing gaps in regional, essential, and public healthcare is a key policy direction for the Ministry, we will develop additional measures to strengthen regional, essential, and public healthcare using AI and telemedicine, alongside the establishment of the new REPH Division.”

A medical industry official also noted, “Following efforts to strengthen regional, essential, and public healthcare, and the prolonged Middle East war, the Ministry of Health and Welfare has repeatedly shown signs of seeking to relax healthcare regulations through telemedicine and new AI technologies. We are closely monitoring the situation, as there have been some instances where sufficient consultation with healthcare counterparts has not been conducted under the pretext of regulatory exemptions.”