Data and Corporate Governance in Pharma and Digital Health: A Necessary Regulatory Convergence.
Carter A., Meinert E., Brindley D.
The regulatory landscape for medical devices has evolved to be in closer alignment with therapeutics, driven by a necessity for greater evidence of device effectiveness and criticality of (companion) diagnostics to clinical care. More recently, digital health has been subject to increased regulatory visibility by NCAs, aligned increasingly closely with medical device regulations. This is due to increasing complexity and risk of digital health technologies – particularly those which inform or replace clinical decision making. Therefore, there is increasing uncertainty in regard to the standards and regulations to which boards should be implementing governance in healthcare.