Some of today’s highlights: the Food and Drug Administration is getting increasingly worried about the prospect of medical device hacks; the world’s best-selling drug may be significantly overpriced; and prostate cancer screenings are out of the dog house.

Read on for the day’s news.

DIGITAL HEALTH

How can the device industry defend against hackers and cybercriminals? The Food and Drug Administration (FDA) and the medical device industry are concerned that this and the coming years will see an onslaught of hacks on life-saving products like insulin pumps and pacemakers. As The Hill reports, the FDA's associate director for science and strategic partnerships at the Center for Devices and Radiological Health has told medical device and health care firms that they "should consider the environment a hostile environment" in which "there are constant attempts at intrusion." The increased sophistication of health care cyber attacks has prompted agencies like the FBI to warn companies about the dangers of ransomware, health record safety, and other types of online warfare—all of which are only expected to become more prominent in the coming years. (The Hill) 

That fitness tracker may not be all that great at measuring your heart rate. A new study by University of Wisconsin in Madison and Iowa's Loras College finds that popular fitness tracker devices like the Fitbit Charge and Mio Fuse are mor or less decent when it comes to measuring a stationary person's heart rate—but become more unreliable when that person is actually doing moderate intensity exercise. When subjects using the trackers did 10 minutes of exercise on a treadmill at 65% of their maximum heart rate, the Fitbit Surge, Fitbit Charge, Basis Peak, and Mio Fuse projected heart rates that ranged from 41 beats per minute slower than the actual rate (as measured by an ECG) to 39 beats per minute too fast. "More research is needed before we can confidently conclude that the monitoring feature for heart rate is sufficient to help clinicians advise their patients about health issues and conduct clinical trails that requires a high level of accuracy and reliability for heart rate measurement," wrote the researchers. (Los Angeles Times)

INDICATIONS

Is the world's best-selling drug cost-effective? The Institute for Clinical and Economic Review (ICER), the notorious biopharma industry pricing gadfly, is giving a thumbs-down to the world's best-selling medication: AbbVie's Humira, a biologic treatment for various common immune system-linked inflammatory conditions like psoriasis, rheumatoid arthritis, and other diseases. To be fair, none of the rheumatoid arthritis therapies analyzed by ICER hit the sweet spot on pricing (relative to patients' health outcomes); but Humira received surprisingly low marks from the organization, which concluded that it would need a list price cut of at least 50% to be considered price-effective. Johnson & Johnson's Remicade and Roche's Actemra fared better than Humira on a cost basis, but were still considered over-priced. AbbVie has responded to the analysis by claiming that ICER's methodology has "significant flaws," and it's unclear whether or not the analysis will affect the burgeoning class of experimental generic copycats (or biosimilars) of these psoriasis and arthritis treatments. (FiercePharma)

THE BIG PICTURE

Federal task force softens its stance on prostate cancer screenings. The U.S. Preventive Services Task Force released revised guidelines on prostate cancer screening Tuesday—and they mark a significant departure from the agency's previous (and controversial) stance. "The decision about whether to be screened for prostate cancer should be an individual one," wrote the agency. "The USPSTF recommends that clinicians inform men ages 55 to 69 years about the potential benefits and harms of prostate-specific antigen (PSA)–based screening for prostate cancer." When it comes to men aged 70 and older, the USPSTF specifically recommends against screening. The agency came out against PSA-based screenings five years ago in a move that raised some eyebrows in the public health community and led to a steep decline in these types of prostate cancer tests. But USPSTF has now come to the conclusion that there may be enough benefits to the screenings that they aren't actively bad for patients. Still, the group notes various potential harms, including just "a small potential benefit of reducing the chance of dying of prostate cancer" and "false-positive results that require additional workup, overdiagnosis and overtreatment, and treatment complications such as incontinence and impotence." (NPR)

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