The medical and health app market is growing rapidly, there’s no question about it. One as yet unanswered question though is how to regulate this emerging industry. This is something we’ve talked about before in a viewpoint published in JAMA Dermatology as well as on iMedicalApps. While it is still early on and we will in many ways have to see which approach is most suitable, its clear that some way of regulating this industry is needed.
Thats certainly not to say that we’re suggesting the FDA or other government regulations are the sole solution. If one thing is clear, its that different apps will require different regulatory approaches depending on what they do (this is the basis behind the FDA regulations). One question that seems to come up frequently is if medical apps should beregulated by individual hospitals/organizations.
I think that question is a somewhat contentious issue so I would like to explain my view in this editorial.
Everyone seems to agree that mobile medical apps need some form of regulation, it is just not clear which is best. Regulation by individual trusts seems like the ideal solution for many reasons; however, I believe this solution is not as clear cut as one might think.
The “for” argument
- Regulating mobile apps within a hospital allows IT departments to assess the quality and safety of mobile apps to their own particular standards and needs
- This approach potentially offers a more dynamic response with departments able to respond quicker than national organizations.
- Healthcare professionals can work using mobile devices with less fear of litigation (provided app is used appropriately as per IT request).
- Hospitals can promote the use of safe apps and highlight these tools to clinicians and patients who may otherwise be unaware of these options — perhaps even integrating them directly into workflow rather then letting them be used covertly.
The “against” argument
- There is the potential to waste a lot of resources by multiple hospitals investing time reviewing the same app.
- While initially this model may be more dynamic, it is dependent on the size of the team and their commitment to reviewing apps e.g. a small team will struggle to review a large number of apps.
- There is also the potential for hospitals to lack the skills needed to accurately assess the safety and reliability of medical apps. The review team will likely need to employ someone who understands the particular nuances of mobile technology to make a full and valid assessment. This may even extend to assessing the base code of the app to ensure it is private and secure.
The bottom line
Any regulatory approach which involves individual hospitals will undoubtedly require the support of the internal IT department to be successful. In turn, this will require a commitment to mobile devices and medical apps. My worry moving to a hospital based regulation system is that hospitals will reject mobile devices for fear of the unknown and a wariness about the inability to securely manage devices which may be used for patient care.
IT departments are traditionally conservative and I think that leaving regulation in the hands of people who may not understand the nuances of the technology does not offer serious protection for healthcare professionals or patients.
However, I do think individual hospitals have a role to play in the regulation of medical apps — particularly in the promotion of safe working practices and potential for workflow integration. Mobile apps offer clinicians a number of advantages in providing safe effective patient care and the sooner hospitals recognize this, the better. The overallbest regulatory approach for medical apps remains to be seen. However, I think one way or another hospitals will be a key stakeholder in their use and future success (or failure).