Governing Patient-Generated Health Data in Post-Treatment Commercial Ecosystems: A Systematic Literature Review across India, the United States and Australia

Abstract

Background: Patient-generated health data (PGHD) now flow from wearables, symptom-tracking applications, remote-monitoring platforms and consumer devices long after clinical treatment ends. In this post-treatment period the data move into commercial ecosystems whose obligations differ sharply from clinical confidentiality. Jurisdictions have responded differently, and the distance between what the law declares and what actually happens to the data is rarely examined directly.

Objective: To review and compare how India, the United States and Australia govern PGHD in post-treatment commercial settings, and to expose the gaps between declared, enacted and enforced governance.

Methods: A PRISMA 2020-guided systematic review was conducted over a curated corpus of 117 bibliographic records. Records were screened against explicit eligibility criteria. Thirty-three further scholarly, legal and policy sources were added purposively to anchor comparative claims. A three-layer analytic lens (declared, enacted, enforced governance) structured the synthesis.

Results: Forty-three corpus records met the criteria, and 33 purposive sources were added, giving 76 sources in total. Seven recurring governance gaps emerged: consent decay, perimeter drift, inference laundering, monetisation opacity, enforcement asymmetry, equity stratification and institutional overload. All three jurisdictions place consent at the centre of governance, but each leaves distinct structural exposures. India has a new but still phasing-in horizontal statute. The United States relies on a sector-specific law with a widening perimeter gap. Australia has a rights-based horizontal statute under active reform.

Conclusions: Governing PGHD requires protection that follows the data and the inferences drawn from it, not the institution that first held it. A five-layer stewardship model and six citable analytic propositions are offered, together with a research agenda.