Apple ($AAPL) has growing med tech ambitions, but those gnarly healthcare regulations have left a sour taste in its mouth. As a result, the Silicon Valley bigwig has stepped up its engagement with the feds, seeking not only to learn by meeting with the FDA but also to change the rules via a lobbying effort that cost nearly $3 million last year.
True, not all of that money went toward altering healthcare and medical device regulations, but it is clear that the company has a strong incentive to do just that due to its growing list of healthcare-related products, such as the Health smartphone app. In addition, at the Consumer Electronics Show in Las Vegas, diabetes care company Dexcom ($DXCM) demonstrated what its continuous glucose monitors would look like on Apple's upcoming smartwatch.
Attorney Jeffrey Gibbs of Hyman Phelps & McNamara went as far as to say that the company's interactions with the FDA aren't unusual, because "Apple is becoming a device company."
But Apple CEO Tim Cook was recently spotted hobnobbing on Capitol Hill with the likes of Sen. Orrin Hatch (R-UT), Bloomberg reports. While not necessarily unusual, the news raises the level of intrigue around the notoriously secretive company.
"They've learned what others before them have learned--that Washington can have a great effect on their business," Larry Noble, senior counsel at the Campaign Legal Center in Washington, DC, told Bloomberg.
In particular, Washington-based agencies have already affected the company's med tech and healthcare ambitions. For example, in 2013 the FDA told the company that if it includes a glucometer for diabetics among its mobile medical applications, the product would be regulated (but perhaps not if it was marketed to promote better nutrition), according to the article. And last year the Federal Trade Commission discussed the privacy concerns surrounding the company's plan to collect and use health care data with top Apple officials.
Apple is not the only tech giant to test the healthcare regulatory environment. Google has med tech ambitions too, and is teaming up with Novartis ($NVS) to develop smart contact lenses. However, Google founder Sergey Brin said last year at a CEO summit that "generally, health is just so heavily regulated. It's just a painful business to be in. It's just not necessarily how I want to spend my time," adding "I think the regulatory burden in the U.S. is so high that think it would dissuade a lot of entrepreneurs."
- read the Bloomberg story