ECCT and SANOFI launch Taiwan Digital Health Report
Addressing competition concerns, reimbursement plans, and integration platforms are the keys to advancement
Digital health has become an increasing trend that is being used to proactively prevent illness. Adopting digital data analysis allows the early detection of disease, which decreases potential future risks. This is according to the "Taiwan Digital Health Report – Considerations for fostering the best ecosystem," which was released today by the European Chamber of Commerce Taiwan (ECCT) and SANOFI. The report examines the missing links in existing structures and the efforts required to propel the digital health industry in Taiwan. It also provides suggestions to support a consolidated, collaborative, and risk-based model to foster digital health innovation, based on experiences from the US, Germany, France, and the UK.
Germany is the first country in the world allows doctors to prescribe digital health applications. The key to its success is the support given by healthcare authorities to DiGA (Digital Health Applications), which acted as a catalyst for the digital transformation. During the first year of launch, over 50 medical apps and roughly 73 million individuals benefited from this certification process. These digital solutions have been implemented in disease areas such as obesity, depression, and sleep disorders. While Taiwan has the advantage of a sophisticated information and communications technology (ICT) industry and a mature healthcare environment, it still faces many unmet needs in developing digital health.
The report was released at an ECCT Premium Event luncheon which was attended by senior Taiwan government officials and international healthcare experts. At the event, Dr. Po-Chang Lee, Director General of the National Health Insurance Administration under Taiwan's Ministry of Health and Welfare (NHIA, MOHW, 健保署署長李伯璋) and Dr. Shiou-Mei Wu, Director General of Taiwan's Food and Drug Administration (FDA, MOHW, 食藥署署長吳秀梅) represented the government as speakers and panelists. The report was introduced by Dr. Hasnaa Fatehi, Founder of QARALOGIC Consulting, after which Anthony Jones, Head of Virtual Healthcare at Sanofi, gave a presentation. The event concluded with a panel discussion moderated by Dr. Hasnaa Fatehi featuring all of the speakers as well as additional panelists Jorge Wagner, General Manager of Novartis (Taiwan) and Ed Deng, CEO of Health2Sync.
Bottleneck of Taiwan digital health software: Difficult approval process and unclear reimbursement criteria
The report highlights the challenge of real-world data application, regulatory approval, and reimbursement issues, concluding that it is necessary to undertake a digital health transformation after the Covid-19 outbreak.
According to ICLG, the International Comparative Legal Guides, there is no clear definition of "digital health" under Taiwan law. So far, only three Software as Medical Device (SaMD)-based digital health solutions have been approved in Taiwan and requirements are getting more stringent. As the result, digital health start-ups may have to first secure a US FDA clearance and then use that to obtain Taiwan FDA approval, which makes the entire process more difficult.
Furthermore, the regulatory pathways for digital health device commercialisation in Taiwan remain unclear. For this reason, people are unlikely to get new, non-reimbursable medical devices and technologies under the sole health insurance system. Digital health solutions which are being actively developed now, are likely to continue to face hurdles if the government fails to improve the reimbursement structure.
Four key considerations in the report
While Taiwan has one of the best healthcare systems in Asia, with extensive data management systems, it does not yet have in place regulations specific to digital health. Based on the experiences of leading digital health markets in the US, Germany, France and the UK, the report provides four suggestions:
- Creation of a cross-agency advocate within the government focused on digital health.
- Creation of an e-health platform, a one-stop shop for manufacturers, regulators, insurers, and other players to work together to support digital health innovators.
- Establishment of a road map for development, certification, approval, and reimbursement specific to digital therapeutics (DTx) solutions
- Definition of pre- and post-market regulations designed to support the quick launch of digital solutions while ensuring patient-centricity.
Learn from leading markets to consolidate digital health data and overcome regulatory hurdles
For digital health to be successful, digital health and Real World Evidence (RWE) need to evolve interdependently with each other. The topic relates to payers and insurers, and has to address issues ranging from easing patients' concerns about sharing data, to regulator/insurer positions on "digitally derived endpoints" to a lack of regulatory clarity regarding RWE requirements.
In addition to the successful case of Germany (cited above), the paper mentions a functional classification system developed in the UK with the intention of providing a pragmatic approach to differentiating the digital health technologies on the basis of functions that are expected to be most widely developed and used. Taiwan could leverage its advantage of a tech-savvy population and mature health-care system, while also learning from others, in order to accelerate the launch and reimbursement of innovative digital health.
The report recommends ways to accelerate digital health development including improving the reimbursement structure, building an e-Health cross-agency platform, and fostering collaboration within the ecosystem. It concludes that this would not only reduce the healthcare expenditure burden, fuel biomedical innovation, and support patients, but would also be aligned with the goals of Taiwan's "5+2 Industrial Innovation Plan" and the "Six Core Strategic Industries initiative".
歐洲在台商務協會與賽諾菲於今日（ 12月7日）共同發表的「台灣數位醫療報告書- 邁向最佳數位醫療生態系統」指出，數位醫療已成預防醫學趨勢，透過數據運用分析，得以即時獲得警訊，降低疾病發生風險。這份報告書檢視並探討現狀的不足與隱憂，以及台灣推動數位醫療產業所需的努力。同時根據美、德、法、英四國經驗，提出數位醫療創新模型，來支持數位醫療創新整合、合作、風險管理。
德國是第一個可開立數位醫療處方的國家，其成功關鍵在於衛生主管機關對DiGA (Digital Health Applications)條例的支持，該條例生效第一年，幫助超過50款健康醫療軟體申請上市，嘉惠約7300 萬名德國民眾，應用於肥胖、憂鬱症、睡眠障礙等疾病。台灣雖擁有卓越資通訊技術及成熟健保環境，卻面臨許多未被滿足的需求。
這份報告書於歐洲商會舉辦的菁英午餐會發布，與會者包含台灣政府代表以及跨國醫療保健專家。健保署署長李伯璋以及食藥署署長吳秀梅為在場的政府代表，擔任講者以及論壇與談人。此份報告書內容由作者、QARALOGIC Consulting創辦人Dr Hasnaa Fatehi介紹，接著賽諾菲香港台灣數位醫療保健處長Anthony Jones發表演說，最後進行由Dr. Hasnaa Fatehi所主持的論壇討論，與談人包括前述講者及台灣諾華總經理Jorge Wagner以及智抗糖創辦人Ed Deng。
醫療器材軟體在台面臨障礙 主因為申請過程困難 給付不明確
借鏡經驗 整合數位醫療數據 破除法規瓶頸