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‘FDA is adapting to fast-changing digital healthcare’
  • By So Jae-hyeon
  • Published 2018.05.11 16:22
  • Updated 2018.05.11 16:22
  • comments 0

The Korean healthcare system and regulations need to change, in line with the emergence of a new market called “digital healthcare,” an expert said.

Choi Yoon-sup, a managing partner at Digital Healthcare Partners, introduced an example of the U.S. government at Bio Korea 2018 Conference in Coex, southern Seoul, Friday. He urged the Korean government to seek aggressive adaptations.

Speaking on the topic “How to regulate medical innovation,” Choi said the U.S. Food and Drug Administration recognized that existing regulatory schemes were not appropriate for innovations such as digital healthcare, and quickly made deregulatory moves.

According to Choi, the FDA announced “Digital Health Innovation Action Plan” (DHIAP) in July last year and is now at the trial operation stage.

Under the DHIAP, if a firm trusted in product quality, patient safety, and proper qualification gets an FDA certification for its ability to collect, monitor, and analyze user data, the firm is allowed to market its product without additional approval.

The principal purpose of the DHIAP is to give FDA certification to an individual company, not to an individual product. The FDA-certified company can shorten months-long approval process and directly showcase its product.

Such streamlined process allows quick releases of diverse products.

Choi noted that large firms such as Samsung, Apple, and Roche were selected as eligible for the FDA’s pre-certification pilot program in September last year.

“As the FDA’s new method allows innovative technologies and products to come out on the market quickly, patients can get access to them on time. So, the FDA is planning to apply this system to genetic testing and artificial intelligence (AI) sectors,” Choi said.

However, the pre-certification system could rather enhance the FDA’s monitoring and management. Whether the FDA will apply objective criteria to certification-seeking companies is the key, he said.

Choi pointed out that Korea’s Ministry of Food and Drug Safety needs to strengthen expertise both in quantity and quality. “The digital healthcare sector is suffering an absolute shortage of manpower, and there should be more support in this area,” he said.

An official at the ministry’s high-tech medical device department said that it was important to consider providing innovative medicines at the right time to allow more treatment options for patients and seek the pharma industry’s growth.

“We are watching on regulatory improvements overseas and preparing related measures internally,” the official said.


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