🤝Capturing consent
In the healthcare sector, the stream of personal data generated during every transaction enables better decision-making and service delivery. It’s hence imperative to empower users by enabling consented sharing of granular personal health data in a secure, privacy-protected manner. In any user-driven data-sharing framework, the data consumer needs to request the user (individual or entity) for their personal data by specifying the quantum of data required, the receiver of the data, the purpose it’s going to be used for, the duration the data is needed for, the frequency of data pull etc. This step is a precursor to the actual sharing of data by the data provider. Maintaining logs of the agreed-upon data-sharing transaction in a non-repudiable, auditable fashion is a key check. The consent given for a specific interaction must be revokable at the user’s will.
Electronic consent is an artefact/ data structure that records and stores the consent for that data-sharing agreement.
Consent artefacts can also be used for non-personal data sharing. An example of this would be a research institute defining the terms to make their clinical trial data available to other innovators to consume.
It’s worthwhile noting that consent artefact is useful in capturing consent along with the bounds of it and is different from wet signature/ e-signature. For some use-cases, especially in capturing agreement in the legal domain, the latter will suffice. For example, in capturing consent for medical procedures an e-signature would be enough, while a consent artefact can be used for sharing data with a doctor for treatment.
The consent artefact in conjunction with the data-sharing framework powers a lot of use cases for different stakeholders:
Healthcare professional/ facility: Used to request past medical records, and share healthcare data with insurance players, other HPs, health techs, govts. etc
Patient (user): Used to share medical records for better medical care, health insurance claims, and preventive care as well as consent to anonymised data aggregation
Quality councils: Uses sampled individual/ aggregated data to ensure quality standards are met and standard treatment guidelines are followed
Government: To audit and ensure that there are no malpractices in data sharing and the user is in control of the data
Insurance: Used to request individual’s treatment data to adjudicate claims requests, request individuals’ medical and related data (from wearables’ etc.) to structure claims
Good Design Principles
Aim for data integrity: Ensure digital signatures and consent artefacts are tamper-proof, securing the authenticity and integrity of critical documents.
User empowerment: Design consent management objects that put patients in control, allowing them to grant, modify, and revoke granular consent easily.
Non-repudiation: This ensures that the origin of the signed content is verifiable and accepted by all involved parties. In this context, "repudiation" denotes the act of a signer denying any affiliation with or responsibility for the signed content.
Auditability: Implement comprehensive audit trails that log consent changes, digital signature actions, and data access to ensure transparency and accountability.
Machine-readable: The signatures and any consent object should be machine-readable to facilitate efficient digital transactions
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