Deregulation Helps Pharma Companies Pursue Digital Health Strategies

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in, titled “Deregulation Helps Pharma Companies Pursue Digital Health Strategies.”

Following is an excerpt:

While it is possible to avoid medical device regulation, much of the software distributed by pharmaceutical companies will end up being FDA-regulated as drug labeling. But at least drug labeling regulation is a familiar beast with more modest requirements, and does not require adapting to unfamiliar medical device regulations.   Consequently, if pharmaceutical companies decide that a digital health strategy will create value by, for example, improving clinical outcomes or reducing the total cost of care, now may be a good time to pursue it.  For the present and near future, the regulatory environment will support quicker execution of these digital health strategies, at a lower cost.