Developers: Get Your Medical Mobile App Verified By IEEE

Key Takeaways

• The IEEE has launched a Global Medical Mobile App Assessment and Registry to help verify the safety and efficacy of medical apps.
• Only a small fraction of the 55,000 medical apps available have been evaluated by regulatory bodies.
• The registry aims to fill the gap in app verification, ensuring compliance with data security and ethical standards.

In an age where mobile applications are increasingly used to manage health conditions, the need for reliable and verified medical apps has never been more critical. The IEEE has recognized this gap and has launched the Global Medical Mobile App Assessment and Registry, a new initiative aimed at ensuring that medical apps are not only effective but also safe for patient use.

Many patients using mobile applications for managing conditions such as depression or chronic pain often assume these apps have undergone rigorous evaluations by regulatory agencies. However, the reality is starkly different. Most of the over 55,000 medical apps claiming to diagnose or treat conditions have never been assessed by any trusted neutral bodies. This lack of oversight raises significant concerns regarding their technical soundness, ethical design, and clinical benefit.

The IEEE's initiative aims to address these concerns by providing a publicly searchable directory of apps that have been vetted against a set of rigorous criteria. This includes assessments of technical soundness, ethical design, compliance with data security and privacy regulations, and clinical efficacy. According to Yuri Quintana, chair of the assessment and registry program, the goal is to help patients, clinicians, payers, and health care systems distinguish clinically meaningful therapeutic apps from those that are merely well-marketed.

One of the key challenges in regulating medical apps is their classification as Software as a Medical Device (SaMD). This classification means that while they are intended for medical use, they often fall outside the purview of traditional medical device regulations. The rapid development and popularity of these apps have outpaced regulatory efforts, leaving a significant gap in oversight.

The IEEE registry is designed to fill this gap, providing a standardized review method developed by a multidisciplinary group of experts. The registry will initially focus on apps aimed at treating mental health conditions, a sector that has seen a proliferation of offerings. Developers can voluntarily submit their apps for evaluation, which will be assessed against approximately 150 consensus-based criteria across three major areas: clinical efficacy, technical soundness, and ethical design.

To be included in the registry, an app must achieve over 85% compliance in each category. The assessment process is expected to take six to eight weeks, and developers will receive feedback on their submissions, allowing them to make necessary adjustments if they do not pass the initial review.

Approved apps will receive an IEEE certification badge, which can be displayed on their websites and marketing materials, serving as a visible proof of their compliance with the registry's standards. This certification not only enhances the credibility of the app but also provides assurance to users that the app has undergone an independent assessment.

As the demand for medical apps continues to rise, the IEEE's initiative is a crucial step toward ensuring that these tools are safe and effective for patient use. By providing a framework for verification, the registry aims to build trust among users and healthcare providers alike.

FAQs

1. What is the IEEE Global Medical Mobile App Assessment and Registry?
   The registry is a publicly searchable directory of medical apps that have been vetted for safety, efficacy, and compliance with ethical standards.
2. How does the assessment process work?
   Developers voluntarily submit their apps for evaluation, which is assessed against approximately 150 criteria. Apps must achieve over 85% compliance to be included in the registry.
3. Why is it important for medical apps to be verified?
   Verification ensures that apps are safe and effective, helping to protect users from potentially harmful or ineffective tools.

Sources and further reading

• IEEE Spectrum: Developers: Get Your Medical Mobile App Verified By IEEE