Make better-informed decisions
With more than 86 million Americans already using a health or fitness app, digital health brings new possibilities for the healthcare industry.
Yet, in a field of 365,000 products, where the vast majority fall outside of existing regulations, such as the medical device regulations, federal laws and government guidance, there has been no clear way to determine if a product is safe to use. This is stopping the national adoption of digital health, particularly in the fields of condition management, clinical risk assessment and decision support.
The Digital Health Assessment Framework has been created to:
- Be an open, objective framework, accessible for anyone to use.
- Support the adoption of high-quality digital health technologies.
- Help healthcare professionals and consumers make better-informed decisions.
- Meet the specific needs and requirements of the US market.
The Framework includes components, specific to the needs of the US, crafted across across four fields:
|Data and Privacy||Clinical Assurance|
Rather than try to reinvent the wheel, the Framework recognizes and points to relevant existing US regulations, and applies several leading international standards and frameworks, ISO 82304-2 in Europe, Digital Technology Assessment Criteria (DTAC) and NICE evidence standards framework in the UK, and DiGA in Germany.
The American College of Physicians (ACP) and the American Telemedicine Association (ATA) collaborated with industry leaders to develop the framework. This includes the Organization for the Review of Care and Health Apps (ORCHA), which has over six years of experience and is equipped to assess digital health products at scale. ORCHA has evolved frameworks for the deployment of digital health in the UK, across Europe and the Middle East.
The Digital Health Assessment Framework is intended to be an open framework, accessible for anyone to use, to support the adoption of high-quality digital health technologies. The Framework will be updated regularly with input from healthcare providers, consumers, technology developers and other stakeholders to reflect changes in clinical practice, and the latest guidelines and best practices.