There are nearly 70,000 digital health apps available on your mobile device right now. Would it shock you to discover that there is no clinical validation to back up most of them? Would it deter you from downloading them knowing they were created by developers exploiting the healthy lifestyle trends in America? Hopefully, like myself, your answer is yes.
Though as easy as it would be to disparage these developers, they are not necessarily the culprit. Upon recognizing multiple disparities in the creation, invention, and utilization of mobile health apps, a lack of clinical infrastructure can be discerned. And without a base research framework, developers cannot easily access patients and their data, leading to the notable lack of validation to potential disruptive solutions.
What most developers fail to recognize though is that healthcare technology is different because it involves patients. This means a necessity to comply with human research stipulations, data confidentiality, security, and privacy sanctions exists. Even greater than market validation, proper healthcare business requires proven, repeatable results.
Here are two reasons your app may be struggling with clinical validation:
1. Understanding IRBs
An IRB, institutional review board, is a council formed with the intent to approve, review, and monitor behavioral and biomedical human research. Responsibility for overseeing all research conducted on human subjects lies with this board. Without proper knowledge of IRBs and how they work, achieving clinical validation is going to a difficult venture.
2. Cost of Clinical Trials
Clinical trials are expensive and the costs of these trials fall into two buckets: patient care and research. Patient care costs will include everything from laboratory tests to health insurance; whereas research costs are those conducive to conducting the trial. The main differentiator is who is responsible for these costs. Patient care costs usually are the responsibility of the patient who is most likely covered by a third-party health plan, but research costs are not the patient’s responsibility and will become the liability of the trial sponsor.