ACP, ATA, ORCHA announce new framework supporting health app safety

WHY IT MATTERS  

As noted on the framework's website, more than 86 million people in the United States currently use a health or fitness app.   Yet the field of health apps is often an unregulated one, say the organizations.  

Using existing U.S. regulations – along with several leading international standards and frameworks, such as ISO 82304-2 in Europe, Digital Technology Assessment Criteria and NICE evidence standards framework in the UK, and DiGA in Germany – the Digital Health Assessment Framework aims to support the adoption of high-quality digital health technologies.  

It comprises four main components: data and privacy, clinical assurance and safety, usability and accessibility, and technical security and stability.  

"There are literally hundreds of health apps and devices for patients and clinicians to choose from, and our goal is to provide confidence that the health and wellness tools reviewed in this Framework meet quality, privacy and clinical assurance criteria in the U.S.," said ATA CEO Ann Mond Johnson in a statement.  

For next steps, ACP says it is launching a pilot test of a library of health apps reviewed against the framework, which will be updated regularly to reflect changes in clinical practice, the latest guidelines and stakeholder feedback.