HIMSS and ACT | The App Association have both weighed in on the Food and Drug Administration's call for feedback on how healthcare stakeholders are using technology to improve clinical research.
The FDA is seeking information about both the scientific and infrastructure challenges that technology poses for conducting clinical research.
Both organizations cited examples of how technology is used in research projects. For example, Intel and the Michael J. Fox Foundation for Parkinson's Research use sensors in wearable devices such as smart watches and fitness trackers to collect and analyze real-time measurements of patient movements, HIMSS pointed out in its letter.
"HIMSS strongly discourages any federal agency from dictating specific technology tools that providers should be using in a particular care delivery model or to conduct research. Each provider will approach its IT structure differently, and should have the flexibility to implement the solutions that they require," the organization says.
HIMSS also refers to previous comments on the Food and Drug Administration Safety and Innovation Act health IT framework, reiterating the need to leverage existing knowledge from the private sector; provide regulatory clarity and consistency to facilitate, rather than impede innovation; and to support an environment of continuous learning.
It urged the FDA to consider how it can support telehealth and remote patient monitoring to improve patient care.
In its letter, the App Association cited benefits of mobile apps in clinical trials including the ability to collect patient-generated health data in real time, higher-quality data aggregated directly from sensors and improved subject retention due to the ease of collecting data.
The challenges include the reluctance to embrace advanced technologies in research due to lack of training and awareness of their benefits; assumed digital illiteracy of potential study participants; and language barriers for particular demographics.
To learn more:
- here's the HIMSS letter (.pdf)
- read the App Association letter (.pdf)