By Deborah Borfitz
August 25, 2021 | Connected diagnostics and care automation could remove one trillion dollars in annual global healthcare spending, or roughly 10% of the outlay in 2022, according to Ken Mayer, founder and CEO of Safe Health Systems, who presented yesterday at the Next Generation Dx Summit. The enabler may well be a digital health and diagnostic platform the company operates in partnership with the Mayo Clinic.
The objective, says Mayer, is to “reduce the cost of low-acuity, routine care at population scale” by moving more point-of-care tests to home use. STD testing alone is expected to balloon from a $105 billion to a quarter-trillion-dollar expense between 2020 and 2025 and Safe Health Systems could cut the average $250 per-test cost in half, he adds.
Telehealth capacity is a key ingredient, which the pandemic has pretty much taken care of, Mayer says, noting that 26% of primary care visits have transitioned to a virtual format. Yet none of the telehealth providers have any diagnostic capacity, or even an interface with Quest and LabCorp.
In addition to smaller margins for diagnostics companies, that translates into the potential for over-prescribing, he says.
Filling the diagnostics gap requires some upgrades, including a means to automatically interpret tests and return results to users, a digital gateway for rapid diagnostic tests (RDTs), an interface with electronic health record (EHR) systems for orders and results, and a public health reporting mechanism.
Beyond the telehealth component, care automation is needed, continues Mayer. Office visit protocols need to be codified for the home environment to encompass EHR cross-referencing, instructing patients how to self-collect samples, and scanning of test results or sending them wirelessly to a smartphone. This will also be critical if payers and pharmacy benefits managers are to reimburse for at-home diagnostic tests.
Safe Health Systems is now working with three providers—Epic, Cerner, and Athenahealth—on the EHR interface piece that would additionally provide linkage to laboratory information systems, Mayer says. The company is also collaborating with Surescripts on improving retail distribution of RDTs.
The sample collection process will need to be simplified, adds Mayer. As has been seen during the pandemic, even professionals have a difficult time administering serology tests on themselves. Safe Health Systems has come up with one easy-to-use alternative called SafeSwab designed with a sponge-like tip for easy sample collection.
Three months ago, the company filed an Emergency Use Authorization request with the U.S. Food and Drug Administration (FDA) for the overall platform, which for regulatory purposes is considered Software as a Medical Device, Mayer says. It serves as a “template” that could be used with multiple CLIA-waived tests, which are generally geared toward screening (e.g., for COVID-19).
Terming the platform “unprecedented,” the FDA has advised Safe Health Systems that it will ultimately want to submit a 510(k) application since the innovation is connected to processes that can activate referrals and prescriptions or signal that triage is needed, says Mayer. Since the device is being paired with simple, CLIA-waived tests at low risk of giving an incorrect result, the main hurdles are to show that sample collection can happen safely at home and the software works as intended.
Outside the U.S., Safe Health Systems has started working with test developers in Europe, Mayer says. The technology could eventually have a “profound effect” in India and Africa where COVID-19 cases and deaths are surging.