The mHealth Regulatory Coalition, an industry group comprised of many of the mobile health IT stakeholders, is weighing in on the issue of when the Food and Drug Administration (FDA) should regulate mobile healthcare hardware and software--and to what degree.
In a new white paper, the group, which includes providers using m-health technologies and organizations that manufacture and distribute such hardware and software, said that the FDA clearly has to define issues before it can resolve them.
Whether a product will be regulated as a medical device depends on the product's intended use. In m-health, a gray area sometimes exists between general health and wellness on the one hand and diagnosis or treatment of a disease or health condition on the other. This makes determining the intended use challenging, the group said.
The group also questioned whether mobile phones and other generic communication hardware become FDA-regulated medical devices "simply because they are promoted for connection to a medical device." Essentially, they wonder if it's necessary to categorize a mobile phone intended to be used to download data from a pacemaker as a Class III medical device, regulated to "the highest degree."
The "FDA's so-called accessory policy that for decades has held that any product intended to be connected to a medical device" is regulated to the same degree as the medical device "produces some illogical scenarios if applied literally in today's connected health environment," the group said.
For more details:
- here's the mHealth Regulatory Coalition letter (.pdf)