Good morning. When I was in China last week, I missed this key news item on digital health–which I’m guessing some of you may have passed over as well, given the seeming prosaicness of the topic.
Last Friday the FDA released its draft guidance on “Clinical and Patient Decision Support Software.” So why, you ask, is this document so significant? Because, as CNBC’s Chrissy Farr reports, the lack of certainty about what the FDA will regulate and what it won’t with regard to digital health applications has been keeping some developers–from giants like Apple and Google to a bevy of garage-based startups–in limbo. And it’s hard to do pretty much anything else when you’re limboing.
The FDA has actually been ruminating over this challenge at least since the turn of the millennium. That’s because the questions that need to be answered are far meatier than they might at first seem, as researchers Roberto Rodrigues, Petra Wilson, and Stephen Schanz explained in a comprehensive 2001 paper:
When does the amount of automated “clinical thinking” done by the software application constitute the “practice of medicine” with all its associated ethical and legal aspects?
To what extent does the application software allow clinicians to examine the underlying logic and to independently evaluate how the software arrived at particular conclusions?
How are the consequences of eventual errors to be dealt with?
Yes, big thinkers were asking those questions 16 years ago and have yet to resolve them. Now throw in a semantic one, which likewise has critical relevance to government regulators: When is the software or algorithm powering a medical device a medical device itself?
For wonky types–and I include myself in that category–the FDA’s litany of examples that constitute devices (and not) is fascinating.
Software that flags potential drug interactions and known drug allergy contraindications (based on FDA-approved drug labeling)? Not a device, according to the draft guidance document.
“Software that analyzes sound waves captured when users recite certain sentences to diagnose bronchitis or sinus infection”? Device.
For all the FDA’s Solomonic judgments, though, there are–and will be more–questions from product developers about inventions that fall between the cracks. One pressing question concerns the latest generation of fitness trackers, particularly as their technology is developed to enable sophisticated diagnoses.
In the draft guidelines, for instance, the FDA says “software that analyzes multiple physiological signals (e.g., sweat, heart rate, eye movement, breathing–from FDA-regulated devices) to monitor whether a person is having a heart attack or narcolepsy episode” is….a device subject to regulation.
So does that mean that a Fitbit (or Apple Watch) that can potentially warn of a dangerous heart arrhythmia–and maybe even help you avoid a stroke, as I wrote about here–is a medical device under the purview of the FDA?
Hmmm. If so, that might slow down the innovation train a bit. But then, I’m guessing that this latest FDA draft may get a few substantive revisions before all is said and done. That’s what drafts are for, after all. Watch this space for more.
|Clifton Leaf, Editor in Chief, FORTUNE|
Net neutrality’s effect on health care. Nature out with an editorial warning about the potential harms of net neutrality repeal (which went through Thursday morning)–including the possibility of a throttling effect on medical research, information-sharing across nations, and health care services themselves. “The changes could affect traffic that routes through the United States, which includes plenty from South America, Central America and the Caribbean. So, in theory, terabytes of data sent from telescope arrays in Chile to physicists in Europe could be stuck in the digital slow lane as ISPs prioritize advertising-heavy social-media messages,” writes Nature. “Or universities and students, especially those in poorer countries, could face prohibitive access and download fees.” Repeal proponents have argued that providing digital fast lanes could help, for instance, people who want telemedicine services; but critics say that only bigger health care companies would benefit from the preferential treatment. (Nature)
We’re learning more about Alphabet’s under-the-radar anti-aging startup. A top executive at Calico, Google parent Alphabet’s secretive anti-aging startup, finally provided some more details on the science being pursued at the company during a conference Wednesday, Axios reports. The early stage research involves mice and yeast and centers on how diet affects aging and health and how cell aging leads to cell breakdowns. Calico’s ambitious goal is to harness greater knowledge about the relationship between aging and disease to tackle everything from Alzheimer’s to cancer. (Fortune)
Pfizer snags another approval for a copycat of J&J’s best-selling drug. Drug giant Pfizer has won Food and Drug Administration (FDA) approval for Ixifi, a “biosimilar” version of Johnson & Johnson’s best-selling anti-inflammatory drug Remicade. While notable as another approval in a new class of cheaper drugs which mimic expensive, branded biologic treatments like Remicade, the approval is a bit of a marketing conundrum for Pfizer–which already has another Remicade copycat called Inflectra on the U.S. market. Pfizer may wind up not commercializing the drug at all as it continues to sell Inflectra. (Reuters)
THE BIG PICTURE
Obamacare enrollment set to fall under shortened sign up period, lack of federal outreach. Obamacare enrollment was off to a red-hot start when the sign up period began on November 1, far outpacing the rate of last year’s enrollments. But overall signups are still expected to fall due to an open enrollment season which has been cut in half, from 3 months last year to just six weeks in 2017 (the sign up period is set to end on December 15 in most states). More than 4.5 million people would have to sign up for plans this week in order to match last year’s numbers, according to analysts. (Reuters)
How Schwab Got Robots to Play Nice With Humans, by Adam Lashinsky
Google Plans Big AI Push in China, by Jonathan Vanian