CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
confiscation of illegal gains, monetary fines (up to RMB50 million or 5% of the turnover of the previous year), suspension of business and, in serious circumstances, the revocation of business licences; • personal liabilities imposed on the person in charge including fines of up to RMB1 million and prohibition from holding certain positions; and • dividing civil liabilities for infringement of per- sonal data into tortious liability and liability for breach of contract. Patient Care With respect to the determination of liabilities in the event injury is suffered by a patient using a SaMD, provisions on product liability and tort will generally apply, ie, the patient can claim com- pensation from either the manufacturer or the seller if the injury is caused by a product defect. Where the party (either the manufacturer or the seller) compensating the patient is not liable for the defect, they may recover their losses from the other. If the defective SaMD was being used by a healthcare institution, including a SaMD using AI technology (to the extent the AI technology is not providing a diagnosis and treatment solely on its own), the patient may also elect to claim compensation from the healthcare institution, which may itself seek to recover its losses from the manufacturer who is liable for the defect. If the healthcare institution is at fault when con- ducting diagnosis and treatment activities, it will also be held liable. The question of whether AI can conduct medical treatment independently and the related liability issues are to be clarified further by the relevant laws and regulations.
In terms of the potential AI bias issue, bias will likely be considered an ethical issue. This will be further clarified by enforcement practice. Commercial Liabilities Contractually, if the supply chain disruption, or the cause of the supply chain disruption, con- stitutes a breach of the agreement between the vendor and the healthcare institution, the failure of the vendor to perform specific obligations, will mean the vendor will bear contractual liabilities as agreed by the parties. If the failure constitutes a violation of the applicable laws and regulations, the vendor may also be subject to punishment The prohibitions and corresponding legal liabili- ties for misconduct are mainly governed by the Criminal Law for criminal liabilities in the PRC, the Cybersecurity Law in the PRC, the PIPL and the Regulations on the Security Management of Network Data for administrative liabilities as well as the Civil Code for civil liabilities in the PRC (see 4.1 Legal Risks of Digital Healthcare ). The specific legal liabilities arising from the use of telemedicine platforms depend on their func- tions and usage. If a telemedicine platform is aimed at providing health education or caring services rather than medical services, the user may file a claim for liability against the owner of the platform. by the relevant authorities. 4.2 Liability Frameworks If a telemedicine platform is registered as a med- ical device and is used by physicians during their practice, the medical institution involved will be accountable for malpractice. If the telemedicine platform is proved to be defective, the patient may also initiate a product liability claim against the manufacturer.
31
CHAMBERS.COM
Powered by FlippingBook