Consent, consensus and an ethical code for health data

As healthcare continues its digital transformation, encompassing everything from wearable devices to clinical decision support software, data has emerged as the crucial factor propelling the development of new technologies. Researchers, clinicians and providers will be – and are currently - collecting, storing, curating and sharing large datasets of health data linked from multiple sources.

But who and what governs the use of such sensitive health data, and what ethical, cultural and community standards do they have to meet? In the absence of clear legal and regulatory pathways to mitigate risks from the collection and sharing of such data, Prof. Tamra Lysaght, external page Hui Yun Chan and external page Hui Jin Toh from FHT and their co-authors collaboratively worked with stakeholders and researchers to create an ethical code for sensitive data.

As hinted in their paper, external page 'An ethical code for collecting, using and transferring sensitive health data: outcomes of a modified Policy Delphi process in Singapore', they use a modified Policy Delphi process – a method of systematically building consensus with a panel of experts and stakeholders over successive rounds of prioritization and voting. The study aims to provide a normatively grounded and culturally appropriate ethical code for guiding researchers in handling sensitive health data, especially in the context of digital health technologies.

Through surveys, interviews and a workshop, the research resulted in these outcomes:

• The sensitivity of health data can vary based on disease type, socio-cultural context, purpose, and other factors, necessitating tiered data access and protection measures.
• The code explicitly identifies health data points that are highly or potentially sensitive, especially within the Singaporean context.
• The study highlighted potential gaps in the regulation of sensitive health data, such as the absence of explicit references to genetic information in Singaporean law.
  
• Neglecting precautions when collecting, using and transferring data could result in ethical debts and jeopardize the feasibility of research.

The research’s end result is a suggestion of a three-tiered ethical framework for consent when dealing with potentially sensitive health data. This foundation of a ‘minimal’ ethical standard leaves the possibility open in the future to how the code will be implemented, and test-proofing the code against stakeholders and patients in multidisciplinary fields.