Beyond the Pill: Sanofi’s Approach to Digital Therapeutics & Driving Improved Outcomes for Patients
“In the context of the COVID-19 public health emergency, the use of digital health technologies, including software as a medical device or other digital therapeutics solutions, may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine. In addition, the use of such technologies has the potential to facilitate “social distancing” by reducing patient contact with, and proximity to, health care providers, and can ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 public health emergency.”
-U.S. Food and Drug Administration (source)
Thanks to mobile technologies like monitoring devices, patients can take control of their health through easy-to-use apps. As software and health care converge to create digital therapeutics, this new breed of life sciences technology is helping to transform patient care and deliver better clinical outcomes. Digital therapeutic products must adhere to each of these foundational principles:
- Prevent, manage, or treat a medical disorder or disease
- Produce a medical intervention that is driven by software
- Incorporate design, manufacture, and quality best practices
- Engage end users in product development and usability processes
- Incorporate patient privacy and security protections
- Be reviewed and cleared or approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use
- Apply product deployment, management, and maintenance best practices
- Publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals
- Make claims appropriate to clinical validation and regulatory status
- Collect, analyze, and apply real world evidence and/or product performance data
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