software as a medical device, la french tech taiwan
Source: TechTaiwan

The first Taiwan-France Digital Health Forum: “Fostering the Best Digital Health Ecosystem in Taiwan” was led by government health officials and industry leaders such as Sanofi, Asus cloud, Wistron Medical Technology, and MediTech and held last week to discuss hurdles facing software as a medical device to go to market, existing and future regulatory and reimbursement frameworks to fuel digital health innovation and accelerate speed to market in Taiwan. 

Government officials include the Taiwan Ministry of Health and Welfare, National Health Insurance Administration (NHIA), Taiwan Food and Drug Administration (TFDA).

Speakers include Prof. Ray-Jade Chen (Professor at the Taipei Medical University), Dr. Hasnaa Fatehi (Founder and CEO of Qaralogic Consulting inc), Mrs. Isabelle Zablit-Schmitz (eHealth Europe & International Director at the French Ministry of Health), and Dr. Shou-Mei Wu (Director General of the Taiwan Food & Drug Administration).

Four major hurdles facing Software as Medical Device (SaMD)

In the keynote session, Dr. Hasnaa Fatehi, Founder and CEO of Qaralogic Consulting, raised current limitations facing software as a medical device (SaMD) that is intended to be used for one or more medical purposes and performs without being part of a hardware medical device.


SaMD, software as a medical device, Qara
Hasnaa Fatehi, Ph.D. (Founder and CEO of Qaralogic Consulting inc). Source: TechTaiwan

She imposed four major hurdles for digital health to achieve scale primarily being regulatory and lack of supportive and agile systems thereof. 

She states the first obstacle “we are still lacking a harmonized set of standards for different devices to talk to each other globally, and then cybersecurity needs to be dealt with along with Internet of Medical Things, because the more things you connect the more vulnerability you will create in your system.”

Secondly, the fact that most software medical devices will be developed by software companies that are new to medical device regulations is still a hurdle to overcome.

Thirdly, the approval process for hardware devices can fall through for software, because the speed at which new software versions are being released to the market is much faster than the speed the regulator is assessing the devices, creating a backlog in the pipeline.

Finally, from the effectiveness standpoint, when hardware medical devices are put through the approval process and assessment by local regulatory agencies like the Taiwan TFDA or the US FDA, information on their clinical effectiveness is also submitted simultaneously. Most of the software, however, now entails some level of artificial intelligence and machine learning, which needs to learn in the market to prove effectiveness, creating a catch-22 situation. 

She later uses Germany, the US, and Japan’s experiences as examples that could shed some light on the issues.

Germany took a bold move in late 2019 for digital health applications

“Germany established a platform for ‘digital health applications’ and in this platform they allow certain software medical device manufacturers to obtain a preliminary approval admission to be listed on the platform directory so that they can be commercialized.

After three months, the product is put on the market and can be prescribed by doctors and also obtain full reimbursement by the national health insurance at the price imposed by the manufacturer. So it is really quite a bold measure. And to be on the preliminary admission, you don’t need to demonstrate or prove effectiveness you need to show levels of security of the device, patient safety as well as data privacy and interoperability requirements instead.

And then it is put on the market for twelve months, prescribed by doctors, and fully reimbursed while collecting information on the effectiveness of this solution. And then after the period of time, reassessment is made for the final listing decision on the directory, and whether there is a disagreement on the price at which it has been reimbursed.

So far it’s been quite successful. Data as of the end of March shows there have been about 65 applications with positive 12 positive decisions.”

Opening of an AI Medical Device Project Office for go-to-market guidance

During the panel discussion session, they addressed Taiwan Food and Drug Administration’s (TFDA) great efforts to enable Software as Medical Device (SaMD) developers in Taiwan. 

Director of the Taiwan Food and Drug Administration Dr. Shou-Mei Wu announced an AI Medical Device Project Office opening on May 7, with an advisory committee to accelerate review time, cross-industry talent training programs, and integrated e-platforms. 

Dr. Wu repeatedly invited the industry to reach out to TFDA for guidance on commercializing their innovation and for working together, hoping to see more applications in the future.

SaMD, TFDA, Software as a medical device, digital health
Dr. Shou-Mei Wu (Director General of the Taiwan Food & Drug Administration). Source: TechTaiwan

Director of National Health Insurance Administration Prof. Po-Chang Lee reaffirmed NHIA’s commitment to reimbursing all innovative technologies with proven clinical outcomes regardless of whether they are drugs or Software as Medical Devices (SaMD).

All panelists agreed that further improvements, including adequate reimbursement criteria specifically designed to assess digital health solutions, are necessary to simplify business and increase market penetration. 

Finally, all stakeholders expressed great appreciation of the benefits cross-organizational collaborations, between industry and competent authorities, would bring to both the French and Taiwanese Digital health sectors. 

Held by La French Tech Taiwan and the French Office in Taipei, in association with the Biotechnology and Pharmaceutical Industries Promotion Office, Taiwan-France Digital Health Forum was a demonstration of La French Tech Taiwan’s commitment to continuously explore areas of potential collaborations between France and Taiwan. 

This encounter served to kick-start the conversation on the future of digital health regulations and reimbursement in Taiwan and created a space for French and Taiwanese companies to learn more about each other and develop relationships.

Panelists include Dr. Hasnaa Fatehi, who led the moderation of the panel discussion with Mr. Anthony Jones (Head of Virtual HealthCare at Sanofi), Mr. Ed Deng (Co-Founder and CEO of Health2Sync), Dr. Shou-mei Wu, Prof. Po-Chang Lee (Director General of NHIA), Mr. Ray Chen (CEO of LongGood MediTech), Mr. Brian Chong (VP at Wistron Medical Technology), Mr. Andy Lu (Smart Health Director at Asus Cloud) and Prof. Ray-Jade Chen.