WEARABLES - INSIDABLES - IOT - CONNECTED DEVICES - QUANTIFIEDSELF

There have been thousands of reported adverse events tied to the Essure permanent birth control implant. Now, researchers are looking at how gynecologic devices like Essure are regulated and approved in the first place.

Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation.

The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015.

Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days).

Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials.

Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns.

Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.

The FDA's draft of cybersecurity guidelines for medical devices does not go far enough in its recommendations for a framework for protecting devices from future attacks, a new report says.

The report, from the Institute for Critical Infrastructure Technology (ICIT), says the FDA is failing to offer options for "regulatory enforcement" that would assure security standards and measures are adopted in the manufacturing of medical devices.

"In practically all matters of cybersecurity within the health sector, the FDA seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed," the ICIT report said.

The authors of the ICIT report, James Scott, Sr. Fellow at the ICIT, a group that advises decision makers on technology and cybersecurity trends in government and healthcare, and Drew Spaniel, Visiting Scholar, Carnegie Mellon University, said that the argument for tough cybersecurity standards typically is undermined by the notion that a regulatory presence stifles innovation.

But current practices are failing to stop the continuous stream of high-profile healthcare hacks. "Due to the industry's continuous lack of cybersecurity hygiene, malicious EHR exfiltration and exploiting vulnerabilities in healthcare's IoT attack surface continue to be a profitable priority target for hackers," the authors wrote.

A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars. 

Unlike popular fitness-tracking devices, such as Fitbit Inc's Fitbit and Jawbone's UP wristbands, these so-called medical-grade wearables require approval from the U.S. Food and Drug Administration - a rigorous regulatory hurdle that first-generation wearables sought to avoid.

The FDA is preparing for the coming onslaught. 

Bakul Patel, FDA's associate director for digital health, told Reuters the agency is reviewing applications for three new senior health scientist positions focused on digital health.

Long criticized by some health-tech entrepreneurs as a barrier to innovation, the FDA is now seen as an important ally by companies eager to show that their devices can improve peoples' health - and eager to get heath insurers to cover them. 

"Consumers, doctors, payers all want to know if a product provides a clinical benefit," said Julie Papanek of the venture capital firm Canaan Partners, who invests in wearables startups. "Working with the FDA is the one way to get the ability to market that benefit."

A key driver in the new wearables wave is the push for so-called value-based healthcare that is part of the Affordable Care Act. The law gives doctors and hospitals financial incentives for keeping large groups of patients healthy. 

Under the old fee-for-service model, hospitals got paid when patients were hospitalized, noted Jody Ranck, a Washington, D.C.-based healthcare consultant. "Now, you can lose money," he said. Instead, healthcare providers are now eager to collect the data that can help keep people out of the hospital - especially those with chronic diseases. "These wearables are just tools to get the health data," said Ranck.

An avalanche of studies - many of them taking advantage of new data-gathering platforms such as Apple Inc's HealthKit, Google's Google Fit and Samsung's SAMI - are under way on a number of chronic diseases, especially in the area of diabetes. "We're going to see a lot of devices over the next couple of years for every chronic condition of mankind that are FDA-regulated because they all involve a treatment loop," Scripps' Topol said.