(Yicai) Aug. 25 -- Brain-computer interface technology in China is transitioning from clinical trials to standardized clinical applications, so demand for patient protection is increasing. Commercial insurance, which plays a key role as a risk-sharing mechanism, has entered the field but remains in the exploratory phase, offering customized plans.

PICC Property and Casualty recently provided coverage for accidental insurance related to invasive BCI surgeries at the Second Affiliated Hospital of Zhejiang University School of Medicine, officially filling the gap in specialized risk protection for invasive BCI clinical translation in China.

But notably, this accidental insurance for BCI surgeries is a targeted, customized plan aimed at specific medical institutions, surgical procedures, and compliant implanted devices. It is not a standardized insurance product that can be mass-marketed or universally adapted nationwide.

Drawing on the history of mature surgical accident insurance in the orthopedic, cardiovascular, and neurosurgery fields, it can be observed that for an innovative medical surgical insurance product to achieve standardization and repeatability, it must achieve at least four key milestones.

The first is establishing a unified risk stratification standard across the industry, creating clear risk grading rules based on different technical approaches, such as intracortical implantation, epidural implantation, and vascular-intervention BCIs, as well as surgical complexity levels and device safety classifications. The second is accumulating sufficient real-world data on claims and compensations, covering both perioperative and long-term follow-up periods, to build a robust sample database that supports actuarial pricing.

The third milestone is developing industry-wide underwriting guidelines that clearly define preoperative patient eligibility standards, qualification thresholds for medical institutions and surgical teams, and compliance checklists for implant devices. The fourth one is establishing a mature and stable reinsurance risk diversification mechanism to effectively mitigate the liability pressure from large payouts associated with high-risk policies.

The launch of a single insurance policy is merely the first step toward the development of the entire industry’s risk protection system. BCI insurance cannot rely solely on the insurance industry, as it urgently requires collaboration among implant device companies, clinical medical institutions, insurance organizations, and regulatory bodies. Together, they must build a data-sharing mechanism and jointly establish unified risk standards.

Under the premise of strictly safeguarding patient privacy and data security, it is essential to continuously accumulate information on adverse events, postoperative complications, and the long-term reliability of devices through secure multi-party computations and de-identified data exchanges.

Only with sufficient long-term clinical data can the underlying logic of risk pricing be clarified, allowing commercial protection in the BCI field to truly move toward standardization and widespread accessibility. This will lay a solid market-oriented risk foundation for the long-term scaled development of the BCI industry.

The author of this article is Deng Yong, healthcare law professor at Beijing University of Chinese Medicine.

Editor: Futura Costaglione