While lobbyists helping write legislation isn't new, the level of cooperation between the FDA and the medical device industry on the 21st Century Cures bill is raising concerns.
The FDA is beginning to regulate how genetic testing companies market DNA tests for health insights, saying that genetic tests can establish paternity or indicate rare diseases, but for heart disease or diabetes, their value is less clear.
New smartphone apps track fertility cycles and pregnancy milestones, but even insurers that offer them aren't sure if they actually lead to healthier pregnancies or reduced medical costs.