Legal ruling on the physician’s duty to inform
On January 27, 2022, the Supreme Court of Korea ruled against a hospital for its
failure to fulfill its duty to inform. The case involved a patient who underwent
spinal surgery in 2018 and subsequently suffered a stroke, leading to paralysis and
cognitive impairment. Although lower courts had previously ruled in favor of the
hospital, the Supreme Court found that the patient was not given adequate time to
consider the risks involved. Only 40 minutes had passed between the explanation of
potential complications and the initiation of anesthesia [
1].
This ruling has sparked a debate within the medical community concerning the
specifics of informed consent, especially regarding the timing of explanations. The
Korean Medical Association has expressed strong disagreement with the decision,
pointing out that it introduces an undefined concept of "timing of
explanation" that is not explicitly outlined in existing medical law.
No physician would oppose the fundamental purpose of the duty to inform, which
ensures patients' right to knowledge and self-determination. Additionally,
this duty acts as a protective measure for medical professionals, provided they
comply with the specified requirements and procedures.
Lawyers often advise that it is safest for doctors to communicate directly with
patients, tailoring explanations to their level of understanding and informing
family members. Additionally, they recommend that physicians establish a strong
rapport with their patients. Moreover, consent forms for operations and other
medical procedures differ in format across hospitals, and the style of explanation
varies among doctors.
Content of digital informed consent
To address these challenges and improve the informed consent process, I propose the
following digital solution:
The Korean Medical Association could develop standardized, interactive
digital educational materials for a range of surgical procedures. These
materials would include 3D imagery and provide detailed information about
the procedures, potential complications, and postoperative care.
These materials could be officially certified by expert committees, patient
advocacy groups, and legal authorities to ensure compliance with the
standards required for patient understanding and legal adherence.
The digital format would incorporate intermittent comprehension checks to
ensure that patients can only provide consent if they demonstrate
understanding.
Upon successful completion, patients could provide their electronic
signatures, with options for further explanations from physicians if
required.
The system would enable remote consent from family members or legal guardians
when appropriate.
This process must be completed at least 24 hours before the scheduled surgery
to be considered valid for non-emergency procedures.
Deposition of digital informed consent forms as non-fungible tokens using
blockchain technology
The deposition of digital informed consent forms as non-fungible tokens (NFTs) using
blockchain technology offers multiple advantages, such as increased security,
transparency, and the immutability of consent forms. It has already been implemented
in areas such as medical education and credential certification [
2]. The procedure can be established as
follows:
Digitizing the consent form: The informed consent form is first digitized,
either by creating it directly in a digital format or by scanning a physical
document into a digital file, such as a PDF or image file.
Smart contract creation: A smart contract is developed on a blockchain
platform, such as Ethereum, to oversee the minting, storage, and access
controls of NFTs. This contract contains provisions to verify the
authenticity of the consent form and link it to a unique identifier.
Minting the NFT: The smart contract associates the digital consent form with
an NFT. Metadata linked to the NFT may contain important information such as
the patient's identity (anonymized or encoded to protect privacy),
the date of consent, and other relevant details.
Storing the NFT: The NFT, which represents the consent form, is stored on the
blockchain to ensure immutability and traceability. The actual content of
the consent form may be stored directly on the blockchain if it is a small
file. More commonly, it is stored off-chain, with a reference link (e.g.,
IPFS, a decentralized storage solution) included in the NFT metadata.
Conclusion
While the system described herein may not address all scenarios, particularly
emergencies, it could significantly improve the quality of information provided to
patients and reduce legal issues associated with routine operations and treatments.
This method would ensure that patients receive standardized, high-quality
explanations, while also protecting healthcare providers by clearly documenting the
informed consent process. However, a legal framework for establishing NFTs on the
blockchain for digital informed consent must be developed. If this innovative
technology can be utilized for digital informed consent, it could reduce legal
conflicts between physicians and patients or their families, potentially
strengthening their rapport.
Authors' contributions
-
All work was done by Dong Wook Shin.
Conflict of interest
-
No potential conflict of interest relevant to this article was reported.
Funding
-
Not applicable.
Data availability
-
Not applicable.
Acknowledgments
Not applicable.
Supplementary materials
-
Not applicable.
References
- 1. Korea Law Information Center. Damages (medical) [a case seeking damages for breach of a
physician's duty to explain] [Internet]; Sejong (KR): Korea Law Information Center; c2022 [cited 2024 Jul 5]. Available from: https://www.law.go.kr/LSW/precInfoP.do?mode=0&precSeq=219331
- 2. Tissier EA, Berglund A, Johnson GJ, Sanzone ZA, Goodbread AP, Parker H, et al. Time until proof of credentials significantly decreases with the
use of blockchain technology and the document management
system. Cureus 2023;15(11):e48920.
Citations
Citations to this article as recorded by
- Unresolved policy on the new placement of 2,000 entrants at Korean
medical schools and this issue of Ewha Medical
Journal
Sun Huh
The Ewha Medical Journal.2024;[Epub] CrossRef
