Digital Health in the Country has grown significantly with the onset of the COVID-19 pandemic, and it has gained recognition among both users and medical professionals. Many startup executives view regulation as their biggest challenge.
According to IDEA, Digital Health is a broad field, but in the country, it mostly encompasses online visitation and online appointment platforms. Startups in this field, like others, face numerous challenges and issues. The executives of these startups consider regulation as their most significant problem.
The problems often raised by these managers include the lack of a specific regulatory body for this sector. In some cases, the Ministry of Health gets involved, and in others, the Medical Board, and, of course, there are no specific laws formulated in this regard. The existing laws are not suitable for Digital Health and are quite outdated.
Mehdi Khodadadi, Secretary of the Nasr Tehran Digital Health Commission, stated: The reality is that responsible authorities do not engage with this field until it poses a challenge for them, and they do not have proactive activities in this regard. In fact, government agencies do not pay attention to Digital Health until it becomes profitable for them, and they may not even fulfill their legal obligations properly. Some institutions do not pay attention to their commitments for months and years, and unfortunately, the government, until it faces a serious problem in this area, does not take steps to solve its problems.
Digital health, with the assistance of the Food and Drug Organization
It’s noteworthy that last week, with the issuance of licenses for the operations of pharmaceutical distribution platforms, many stakeholders and media outlets in this field came to believe that the government has recognized the importance of digital health. The Food and Drug Organization is also expected to formulate and announce its regulatory laws in the next four months.
But a few months ago, the government, in line with the Seventh Development Plan, declared that healthcare service providers’ systems must have laboratory evaluation approval from the Ministry of Health’s software and compliance certificates with electronic health record standards. Otherwise, these systems are not authorized to operate in the healthcare process, from prescription to drug consumption and the provision of healthcare services.
According to Article 183 of the Seventh Development Plan, which pertains to electronic health records, the Ministry of Health is obligated to formulate a program, with the assistance of several ministries and other organizations, to complete and integrate electronic health record systems.
Is the Ministry of Health Supportive?
Mehdi Khodadadi, the founder and CEO of Dr. Saina, discussed regulatory challenges. He stated, ‘In 2018, the Digital Health Startup Working Group was established within the Nasr Organization. Over the years, I have seen more inaction. Our problem here is that we need legal recognition in digital health.’
He further explained, ‘In the whole world, healthcare is not a private matter, and services in this field are provided as a government commitment to the people. So, we are operating in a domain of government authority and need to have constructive interactions.’
How has the recent resolution by the government’s legal office regarding the Ministry of Health’s efforts to improve digital health platform services, along with other regulatory matters, progressed so far?
Continuing this conversation, he elaborated: ‘This matter refers to Resolution 1401/05/04 (July/26/2022), in which the Council of Ministers was required to draft regulations for digital businesses. This regulation was supposed to be drafted by 30 Mehr 1401(October/22/2022). However, despite our follow-ups through professional organizations or chambers of commerce, this has not happened, and a two-week extension was granted in Tir month (July), during which the regulation has still not been formulated.
Regarding other user concerns, he added: ‘In terms of eligibility, it should be noted that if someone holds a medical degree from the Ministry of Health, Treatment, and Medical Education and has obtained a medical practice license, their eligibility is registered in Dr.Saina based on the information available in the medical degree. Moreover, concerning identity verification, we have witnessed positive developments due to the necessary inquiries from the Shahkar system, the Civil Registry, and the Medical Board, so there are no concerns in this regard.
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