Seeking a common framework for assessing apps.
With more than 86 million Americans already using a health or fitness app, digital health tools bring new possibilities for improving health. 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 slowing 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 Digital Health Assessment Framework was developed jointly by ACP, the American Telemedicine Association, and ORCHA. ORCHA has evolved frameworks for the deployment of digital health tools in the UK and across Europe and the Middle East, and their experience formed the basis for adapting global best practices to support US regulations, guidelines and expectations. A series of workshops was conducted with relevant experts to identify the appropriate assessment criteria for the US. ACP members primarily reviewed and revised the clinical assurance and usability criteria, while the ATA focused on gathering input regarding the technical criteria and usability. ACP greatly appreciates the leadership role the ATA played to bring the DHAF into existence.
Key Components of DHAF
The DHAF is a comprehensive set of criteria intended to identify high-quality, safe and effective digital health tools (or apps). The criteria are organized into four domains:
Data & Privacy
- Adherence to federal laws designed to protect the rights and freedoms of individuals.
- A deeper dive into laws that are specific to individual products, such as the need for HIPAA compliance and COPPA
Clinical Assurance & Safety
- Is the app safe and effective, based on evidence requirements related to the complexity of the app?
- Does the content draw on high-quality clinical guidelines (including ACP Clinical Guidelines, USPSTF Guidelines, and similar) or other respected sources?
- For patient safety, is the app a medical device as outline by FDA Digital Health Requirements?
View more details about the clinical assurance & safety process.
Usability & Accessibility
- Design and development; accessibility; usability; user support
- Compliance with design standards
Technical Security & Stability
- App was built in compliance with the secure coding practice guidelines of the OWASP (Open Web Application Security Project)