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Revolution in medical devices expected, as feds chop decades-old rules

The feds are waiving rules and penalties against doctors and companies who can now diagnose patience through Zoom, Skype and other videoconferencing for the first time.

Computer-delivered health care is about to boom, experts say, pointing to dramatic deregulation by the Trump administration.

This means that new products could come to market, new telehealth startups could be funded and test results for coronavirus could show results faster.

Telehealth is more than video chat with doctors. The Health Resources Services Administration’s definition includes any use of electronic information and telecommunications technologies that support long-distance clinical health care.


One barrier to telehealth advancement was the Health Insurance Portability and Accountability Act. Better known as HIPAA, the 1996 law prevented doctors from sharing their patients’ health information without the patient’s consent.

Telehealth-enabled doctors often use video conferencing software like Facetime, Skype or Zoom to talk to and evaluate patients. That means a third party, like a video conferencing platform, may have access to doctor-patient conversations about sensitive medical information.

The Department of Health and Human Services announced March 28 that it will look the other way when doctors and nurses violate that part of the law.

HHS said its Office for Civil Rights “will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies,” but only “during the COVID-19 nationwide public health emergency.”

The Trump administration also broadened access for seniors under Medicare to access telehealth, and announced an agreement with major health insurers to cover telehealth services that allow so people can consult doctors and access some medical care from their homes.

One beneficiary could be a medical device startup called Fluxergy. It’s marketing a lightweight, fast and portable coronavirus test whose software can enable health care providers who aren’t doctors to test patients at their bedsides.

Dr. Davey Smith, professor of medicine and head of the University of California-San Diego Division of Infectious Diseases and Global Public Health, led the physician-scientist team responsible for validating the test. He told Zenger News that the Fluxergy option is perfect for testing individual patients who need a quick answer.

The wait time to get COVID-19 test results is typically four to five hours; Fluxergy produces an answer in just one hour.

“The Fluxergy system is very low complexity, so basically anybody can perform the test,” said Smith. “Once you perform the test, it takes about an hour to get the results back. We are getting ready to start using it in a cancer center [in California].”

Many medical device companies use large pieces of equipment to process coronavirus tests, Smith said, requiring “more technical savvy for the workers to run it.”

He hopes Fluxergy could help accelerate widespread testing. The company submitted its test for FDA emergency approval on March 30,

“We’re desperate for tests,” Smith told Zenger. “We need to know how far and how deep the virus has penetrated the population, and that means screening people who are asymptomatic.”

He worries that without federal stimulus money from pandemic-response legislation, innovative companies could run out of money before they can help the nationwide effort to track and stop the virus.

“I know the FDA is pretty backed up right now,” he said. “The thing is, money is strapped, and they talk about all this stimulus money but none of it is at the hospital side or the research side. Everyone is running all these tests on their own dime, and people keep saying, where is the money?”

Ophthalmologist William Mallon told Zenger the relaxed HHS regulations could help American eye patients too.

Mallon founded GlobeChek, a tele-health technology that allows doctors to evaluate patients’ eyes and discuss the results with them remotely. He said although 80 percent of blindness in the United States is preventable, people rarely visit eye doctors because they seldom realize they have a problem until it’s too late.

Fewer still are visiting ophthalmologists in the age of coronavirus, Mallon said. That’s where his innovation, an eye-exam kiosk, comes in.

“We can do it in 7-9 minutes and it’s basically a comprehensive eye exam,” he told Zenger. A GlobeChek examination costs about $100, but Mallon hopes insurance companies will soon cover the cost.

GlobeChek is only available in Vero Beach, Florida, so far. But Mallon sees a future expansion nationwide, in shopping centers, retail stores, airports and other public spaces.

“You could be in a mall or an airport and you’ve got two hours to kill, you go up to a GlobeChek kiosk, get [your] eyes examined without any human contact, then walk out the door,” he said. “When the patient goes home, the info goes to a doctor, then we follow up with a patient and do a consultation on video or phone and review those findings with the patient.”

Doctors can detect diabetes, glaucoma, heart disease and sleep apnea through routine eye exams. Mallon said he’s fielding calls “left, right and center” from universities, Veterans Affairs hospitals and a hospital in New York City.

“We’re going to be going up to NYC in a couple days to have [a hospital] use GlobeChek,” he said, “for not only patients but the healthcare providers themselves.”

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