Statement of the Problem: Digital health is an area of interest for research institutions and governments around the world due to its potential to limit the global burden of disease through better disease prediction and prevention. In the digital age, law-makers have immense power over the pervasiveness of digital health technologies in our society. Indeed, oftentimes, it is the law which provides the foundations for what is permissible or not; how technologies can be created, developed and used clinically or commercially. Thelaw may also establish rules that impact on civil rights, privacy, security and data ownership which are fundamental societal issues. This research considers a case study to examine how laws are made within a specific field of digital health to determine the extent by which substantive legal issues were considered by law-makers, and how accountable law-makers were for the reasons of their decisions. The case study was the Australian My Health Record System (national e-health record system).

 

Methodology & Theoretical Orientation: A historical documentary review of public record information was undertaken to ascertain information on law-making processes utilized. The theoretical basis for the review was the legal process school, established by former Harvard Law Professors, Henry Hart and Albert Sacks. Preliminary Findings: The law-making process for Australian e-health record system did not encourage the production of high-quality references in support of statements of clinical efficacy. Further, at times, no references were provided to support statements of clinical efficacy. Additionally, it was found that substantive legal issues were not appropriately assessed, including those of data ownership and human rights, despite the fact that human rights concerns were brought to the attention of the federal government by the Parliamentary Joint Committee on Human Rights, and the Human Rights Commission.

 

Recommendations: The paper proposes a framework for law-making. It comprises of a series of broad considerations for law-makers in the field of digital health. The framework could have applications from the level of private decision-making through to legislative decision-making, and with further assessment, it could potentially be applied across jurisdictions. The proposed framework consists of 8 pillars of law-making founded on the belief that principles of human rights, clinical and societal benefit, as well as harm and risk reduction are essential considerations of law-making in the field of digital health.