Self-diagnosing, Monitoring Apps Embraced With Caution

Alicia Ault

April 08, 2016

While optometrists have taken up a legislative and regulatory battle against a smartphone app they say threatens patient health, many specialties see upsides to apps that purport to help patients self-diagnose or monitor health.

The number of health apps is exploding, with some 165,000 counted by the IMS Institute for Healthcare Informatics in September 2015. As reported by Medscape Medical News, the offerings are a jumble of largely unregulated and sometimes uninformative programs. Some have raised caution flags, while others have been embraced by some, but not all, clinicians.

"Do-it-yourself approaches to medicine are becoming more prevalent," Andrew Freeman, MD, told Medscape Medical News. "We have to be able to embrace this sort of technology," because it has the potential to improve the physician-patient relationship, said Dr Freeman, who is on the American College of Cardiology's (ACC's) Best Practice Quality Improvement Committee.

The trick is determining what's safe and validated and produces good outcomes. "We shouldn't put our faith in an unvalidated tool," said Dr Freeman, director of clinical cardiology at National Jewish Health in Denver, Colorado.

Remote monitoring, wearable devices, and "big data" will soon be a huge aspect of clinical practice, said Nathaniel DeNicola, MD, MSHP, a senior fellow at the Penn Social Media and Health Innovation Lab at the University of Pennsylvania in Philadelphia. "It's better to embrace it now and get ahead of the pitfalls than to ignore it," Dr DeNicola, the American Congress of Obstetricians and Gynecologists' (ACOG's) Expert Consultant in Mobile and Social Media, told Medscape Medical News.

The market is moving faster than regulators' ability to keep up — with the technology, and the promises being made. "App developers basically have free rein for direct-to-consumer advertising," said Dr DeNicola. The claims made by apps would never fly for a medical device or pharmaceutical. "It's a Wild West moment where there are no rules," he said.

"Patients have a hard time knowing what they're getting," Karen Edison, MD, deputy chair of the American Academy of Dermatology's (AAD's) Telemedicine Task Force and chair of the dermatology department at the University of Missouri in Columbia, told Medscape Medical News. "There's no good way to warn the public about these things."

While most apps are simple monitoring programs, some — like the Opternative app being opposed by optometrists — are veering into medical practice, said Dr DeNicola. "More and more, apps will blur that boundary," he said.

Optometrists See Danger

The American Optometric Association (AOA) has convinced legislatures in Georgia, Nebraska, South Carolina, and Oklahoma to consider banning Opternative. The app, launched in July 2015, lets patients do their own refractory eye exams and receive a prescription for glasses or contacts for $40.

The optometrists successfully blocked Opternative in Indiana. A law signed by the governor in late March allows remote eye exams and treatment, but prohibits telemedicine prescribing of glasses or contacts — essentially rendering Opternative illegal.

AOA has asked the US Food and Drug Administration (FDA) three separate times to investigate Opternative, including on April 4, when it sought removal from the market. The FDA complaint alleged that the app could miss a diagnosis, that inaccurate prescriptions could harm patients, and that the prescription is created without meaningful input from an eye doctor or other clinician.

"There are simply too many questions about the accuracy of this so-called eye exam. That's why the AOA is alerting the public and urging federal and state officials to enforce their statutory and regulatory duties of patient safety and consumer protection safeguards," said AOA President Steven A. Loomis, OD, in a statement.

Opternative chief executive officer and cofounder Aaron Dallek told Medscape Medical News that AOA's claims "are false and mischaracterize the proven safety and effectiveness of Opternative's technology." He said the app makes it clear that it's not a replacement for an "eye health exam," and patients are encouraged to get such an exam every two years. Consumers can't take an Opternative exam more than four times without certifying that they've "received an eye health exam first," said Dallek.

The company uses licensed ophthalmologists and the technology operates under the supervision of trained professionals, he said, adding that it is also "registered as a medical device with the US Food and Drug Administration."

Potentially Deadly Mis- or Missed Diagnosis

Most apps simply give consumers a more tech-friendly way to monitor insulin levels, fertility, blood pressure, or heart rate. The original — and still most accurate — "digital approach" to measuring heart rate is two fingers on the pulse point, said Dr Freeman.

But he sees a certain empowerment that comes with putting more data into patients' and doctors' hands.

He encourages his patients to download and use the ASCVD Risk Calculator, an app designed by the ACC and the American Heart Association that gives a 10-year risk estimate for cardiovascular disease. "It leads to a more informed discussion with the patient," said Dr Freeman, who acknowledges a potential downside: patients could end up in harm's way if they think they have a low risk and never consult their physician.

Apps that claim to diagnose pose greater risk. "Medicine is more of an art than patients think," he said. "Knowing what to do with that data point is really where the training and the apprenticeship of medicine comes in."

Dermatologists also have concerns about misdiagnosis and missed diagnoses. The field has faced an onslaught of apps and telemedicine services that purport to diagnose skin cancer. Some are helpful, said Dr Edison. She said she recommends apps like the Mole Mapper because they give patients "a tool they can use to monitor their moles so they can better know when to go in and get their moles checked."

The AAD hasn't specifically addressed apps, but it has issued a lengthy position paper on "direct to consumer telemedicine" that, among other things, calls for dermatologists associated with the services to be board-certified in the same state where the patient resides. Telemedicine is ideally conducted by the patient's own dermatologist or in their health system so medications and allergies can be reviewed and communications can be easily made with the care team, Dr Edison said.

"We are aware of burgeoning quality problems" with current telemedicine being offered to consumers, she said. A study she helped conduct that will be published soon will shed new light on the services.

Ordering Up Contraception

The explosion of health-related apps has been felt most keenly in obstetrics and gynecology. Some 1800 apps target women with programs to monitor menstruation, ovulation, and pregnancy and keep track of the rhythm method. Recently, a few apps began delivering contraception and tests for sexually transmitted diseases directly to the home, with just an online consultation. Taking it one level higher, a new app — AirStrip's Sense4Baby — will let women monitor fetal heart rate at home with a smartphone or smart watch.

The California Planned Parenthood chapters launched an app in June that allows men and women to order STD test kits, and, if they test positive, to get treatment — without going to a doctor. Another Planned Parenthood app lets Minnesota and Washington state residents talk to a clinician online or face-to-face through secure video, and then receive birth control or an STD test kit and treatment by mail.

With Nurx, a woman answers some questions, and, after a review by a physician, the prescription is issued, and oral contraceptives — including emergency contraception — are shipped directly to the home. Nurx, which is currently only available in California, is free for women with insurance.

Dr DeNicola said he welcomes these apps because they increase access to contraception. ACOG is more concerned about apps like Sense4Baby because they seem to be moving into the practice of medicine. The yet-to-be-introduced app was approved by the FDA in April 2015 and showcased by Apple in September at its Apple Watch OS2 introduction.

"This one gives us pause...because getting an accurate fetal heart rate is not necessarily a simple thing to do," Dr DeNicola said, adding that being wrong can have dire consequences.

But he and an ACOG spokesperson said that the College is not going to any state legislatures or any federal agencies seeking to block such technology.

Drs DeNicola, Edison, and Freeman have declared no relevant financial relationships.

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