Defining regulatory compliance in digital health

New and agile approaches to accelerate digital innovation in healthcare

Defining regulatory compliance in digital health

Digital health is rapidly changing the way pharma professionals predict, monitor and help to manage health. Whether it is software-as-a-medical-device (SaMD), artificial intelligence (AI), clinical practice technologies or consumer health technologies such as wearables, apps or fitness trackers, regulators must start revolutionizing their approaches to support innovation and keep pace with market growth.

While data is not new to the healthcare field, there are new challenges for regulators to consider. One is the exponential growth in both data volume and complexity throughout the healthcare value chain. Another challenge is the adoption of new technology platforms, tools and methodologies in digital health and data analysis.

Recent changes in digital health innovation will affect their approval and use, particularly as regulatory bodies are feeling the pressure to implement new models to address technology – and software as a subset – and adopt a more agile way of working. In this report, we examine the challenges and opportunities of implementing digital solutions and the impact of SaMD, big data and cybersecurity on regulatory compliance and healthcare.

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