While the use of artificial intelligence (AI) has revolutionized the healthcare industry, generative AI is prohibited from producing patient health records to protect people’s personal information, the Ministry of Health and Welfare said.
According to the “Guidelines on the Qualification and Classification of Software Used in Healthcare” (醫用軟體分類分級參考指引), the use of processing software for collecting, saving, analyzing, displaying and transferring health conditions, physiological parameters and medical records should be within healthcare facilities, personal homes and telemedicine; while AI-assisted medicine is managed by medical device software.
The Food and Drug Administration (FDA) in May 2021 established a smart medical devices office, providing consultation to people in the industry. Most of the items that have undergone review by the office are AI-assisted medical device software for screening, detecting and diagnosis, listed as Class 2 (moderate risk) medical devices. Such devices are new and complicated, and there are more than 100 cases waiting to be reviewed.
Photo: Reuters
AI-assisted medical devices that have obtained FDA approval included ones analyzing images to diagnose cardiovascular diseases, tumors, eye disorders, bone fractures, and chest and abdominal abnormalities, and many hospitals have been collaborating with medical device manufacturing companies.
Companies such as Ever Fortune AI Co Ltd (長佳智能) have developed the NeuroSuite computed tomography intracerebral hemorrhage assessment system and obtained US FDA approval last week.
The Taipei Veterans General Hospital and Taiwan AI Labs (臺灣人工智慧實驗室) also collaborated in developing DeepMets, a brain metastasis detection module, which received approval in Vietnam in August and is on track to enter the Southeast Asian medical device market.
However, the use of generative AI, such as the chatbot ChatGPT, is prohibited from producing health records.
According to Article 12 of the Physicians Act (醫師法), physicians should produce patient health records, either through handwriting or typing, and they cannot use software to produce them, the ministry’s Department of Medical Affairs deputy director Liu Yu-ching (劉玉菁) said.
As generative AI would need to upload patient health records with personal information to another database other than the National Health Insurance’s, it cannot be allowed, she said.
Some hospitals say they use AI-assisted speech tools for producing health records, but they are actually speech-to-text software, not AI, Liu said.
“However, as technology advances rapidly, if there are doubts about the use of certain technology, it will be discussed and reviewed,” she said. “The current regulations are not unadaptable, but so far the ministry still has limits on AI application in the healthcare industry.”
Hope Foundation for Cancer Care chairman Wang Cheng-hsu (王正旭), a physician, said the efficacy of AI-assisted diagnosis technology needs to be carefully tested and verified, while laws need to be updated to keep up with new technologies.
Physicians must be responsible to their patients, so being transparent about how information is collected is important, Wang said, adding that explaining to them how the treatment procedures would be assisted by AI, and if it has obtained government approval, it would ensure that patients have confidence in the treatment.
While many people often complain about “three longs and two shorts” — waiting too long to book an appointment, seeing a doctor and retrieving the prescribed drugs, and having too short time to ask questions to the doctor and getting explanations — AI-assisted technology can reduce the time doctors need to spend on low-level administrative work, Taiwan Young Patient Association vice president Eric Liu (劉桓睿) said.
Additional reporting by Lin Hui-chin and Chen Yung-chi
Kenting National Park service technician Yang Jien-fon (楊政峰) won a silver award in World Grand Prix Photography Awards Spring Season for his photograph of two male rat snakes intertwined in combat. Yang’s colleagues at Kenting National Park said he is a master of nature photography who has been held back by his job in civil service. The awards accept entries in all four seasons across six categories: architectural and urban photography, black-and-white and fine art photography, commercial and fashion photography, documentary and people photography, nature and experimental photography, and mobile photography. Awards are ranked according to scores and divided into platinum, gold and
The Chinese Nationalist Party (KMT) caucus yesterday said it opposes the introduction of migrant workers from India until a mechanism is in place to prevent workers from absconding. Minister of Labor Hung Sun-han (洪申翰) on Thursday told the Legislative Yuan that the first group of migrant workers from India could be introduced as early as this year, as part of a government program. The caucus’ opposition to the policy is based on the assessment that “the risk is too high,” KMT caucus secretary-general Lin Pei-hsiang (林沛祥) said. Taiwan has a serious and long-standing problem of migrant workers absconding from their contracts, indicating that
SPACE VETERAN: Kjell N. Lindgren, who helps lead NASA’s human spaceflight missions, has been on two expeditions on the ISS and has spent 311 days in space Taiwan-born US astronaut Kjell N. Lindgren is to visit Taiwan to promote technological partnerships through one of the programs organized by the US for its 250th national anniversary. Lindgren would be in Taiwan from Tuesday to Saturday next week as part of the US Bureau of Educational and Cultural Affairs’ US Speaker Program, organized to celebrate the 250th anniversary of the signing of the Declaration of Independence, the American Institute in Taiwan (AIT) said in a statement yesterday. Lindgren plans to engage with key leaders across the nation “to advance cutting-edge technological partnerships and inspire the next generation of scientists and engineers,”
TRADE-OFF: Beijing seeks to trade a bowl of tempura for a Chinese delicacy, an official said, while another said its promises were attempts to interfere in the polls The government must carefully consider the national security implications of building a bridge connecting Kinmen County and Xiamen, China, the Public Construction Commission (PCC) said yesterday. PCC Commissioner Derek Chen (陳金德), who is also a minister without portfolio, made the remarks in a meeting of the legislature’s Transportation Committee, after Democratic Progressive Party Legislator Hsu Fu-kuei (徐富癸) asked about China’s proposal of new infrastructure projects to further connect Kinmen and Lienchiang (Matsu) counties with Xiamen. China unveiled the bridge plan, along with nine other policies for Taiwan, on Sunday, the last day of Chinese Nationalist Party (KMT) Chairwoman Cheng Li-wun’s (鄭麗文) visit
RSS