Daily Briefing – September 28, 2019

“The Food and Drug Administration has issued new guidelines on how it will regulate mobile health software and products that use artificial intelligence to help doctors decide how to treat patients. The guidelines, contained in a pair of documents released Thursday morning, clarify the agency’s intent to focus its oversight powers on AI decision-support products that are meant to guide treatment of serious or critical conditions, but whose rationale cannot be independently evaluated by doctors. To further define the types of products that will require greater scrutiny, the FDA gave the example of a clinical decision support (CDS) tool that, without explaining its rationale, identifies hospitalized type 1 diabetic patients at high risk of severe heart problems following surgery. If such a product were to give an inappropriate recommendation, the agency said, it could result in serious harm to the patient. “FDA is trying to be very clear about where we are focusing our oversight and where we are not,” Bakul Patel, director of the FDA’s division of digital health, said in an interview. “We are working with our stakeholders to create that clarity.” In releasing the guidelines on mobile health software and CDS tools, the FDA is attempting to communicate how it will implement provisions within the 21st Century Cures Act, a law passed in late 2016 that sought to exempt several categories of health software from FDA review. The legislation gave FDA discretion to determine which specific products will fall under its purview.”

“The U.S. military’s suicide rate among active-duty service members has climbed over the past five years, according to a Pentagon report released Thursday, as defense officials acknowledged a troubling rise that they said was similar to national trends. Some 541 service members died by suicide in 2018, including 325 active-duty troops, the report said. The active-duty suicide rate was about 24.8 per 100,000 service members, up from 21.9 in 2017 and 18.7 in 2013. “Although the suicide rate among most of our military populations is comparable to civilian rates, this is hardly comforting, and our numbers are not moving in the right direction,” Elizabeth Van Winkle, the Pentagon’s executive director of force resiliency, told reporters on Thursday. Service members who die by suicide continue to be mostly male, white and under the age of 30, said Karin Orvis, director of the Pentagon’s defense suicide prevention office. The Army and Marine Corps, the services with the highest suicide rates, also have the greatest percentage of men.”

“Walmart’s Sam’s Club announced a pilot program Thursday in partnership with Seattle-based telehealth startup 98point6 and health-care company Humana to offer affordable health-care services to its members. Early next month, Sam’s club members in Michigan, Pennsylvania and North Carolina can buy one of four bundles ranging from $50 to $240 annually to access primary care, alternative medicine, optical, and dental services for up to six family members. The program later may expand to members in other states, according to a Sam’s Club news release. The discount health program called Sam’s Club Care Accelerator Together with Humana includes — among other offers — free prescriptions for some medications; prepaid health debit cards ranging from $5 to $100, depending on the bundle; savings on dental services; and $1 virtual clinic visits through the text-based app 98point6. Sam’s Club stressed that the program is not in lieu of a health-care plan. “We are lowering the barrier for people to take care of themselves,” said Lori Flees, senior vice president of Sam’s Club Health and Wellness. Sam’s Club estimates the Club Care Accelerator program will save members $400 to $1100 annually.”

Amazon.com (NASDAQ:AMZN) has taken down so many businesses in the consumer goods sector that just poking its head into the smaller healthcare arena should be enough to make anyone nervous. Amazon’s latest healthcare sector bomb landed in the growing market for telemedicine services. The retail goliath’s new pilot program, called Amazon Care, will be limited to Amazon employees in and near Seattle, but fear of competition still led Teledoc Health (NYSE:TDOC) shares around 6% lower within hours of the announcement. Just how frightened should Teledoc shareholders and other healthcare investors be at the moment? Here’s what you need to know. What’s happening? Amazon finally launched Amazon Care, a virtual health clinic that combines telemedicine with in-person services and pharmaceutical sales. Through the Amazon Care app, patients can text chat with a nurse in minutes, or set up an in-app video visit with a doctor or nurse practitioner. If an in-person exam or a vial of blood is necessary, the program employs mobile nurses who will visit the patient at home or the office. Last January, Amazon bought a prescription drug delivery business called PillPack that will probably play an important role in Amazon Care. That’s because the service also includes prescription drug delivery, so employees can handle all aspects of a doctor visit without leaving their homes or offices.”