Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as wearable sensors that provide personalized feedback, smart prosthetics, health and fitness apps, software-driven diagnostics, and therapeutics, to name a few) are now commonplace. To preserve their place in the market, digital healthcare innovators must decide whether to patent their technology, keep their technology as a trade secret, or release technology with the hope that the first mover advantage turns them into industry leaders.

Adding to the mix for decision-makers, recent guidance from the U.S. Supreme Court has left many in the industry wondering whether their software-based tools are even eligible for a patent. In an attempt to clarify its position on this issue, the United States Patent and Trademark Office (USPTO) issued Interim Guidance for subject matter eligibility under 35 U.S.C. § 101 on December 15, 2014. With regards to software, these new guidelines largely follow the previous interim guidelines issued on June 25, 2014, in view of the recent Supreme Court decision in Alice v. CLS Bank, with some additional details. These recent developments at the USPTO should be considered by decision-makers weighing their options on when and how patent protection is sought. The following article discusses the practical effect of this new guidance with particular emphasis on aspects of the guidance that are relevant to digital healthcare...