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The Mayo Clinic, in partnership with the digital health start-up Safe Health Systems, has launched a new health and connected diagnostics platform that can be used to store COVID-19 testing and vaccination data, as well as test results for sexually transmitted diseases (STDs) and other medical conditions.
This collection of apps and services, part of the Mayo Clinic Platform, can be used to create a kind of “health passport” that might help employers, schools, and entertainment venues verify which individuals are COVID-free and/or immunized. It’s also designed to support the further expansion of telehealth, which has grown exponentially during the coronavirus pandemic.
“Mayo Clinic Platform believes that the future of virtual care includes on-demand diagnostic testing, including the tracking of lab results and proof of vaccine administration in support of the post-COVID-19 new normal,” John Halamka, MD, president of the Mayo Clinic Platform — the organization’s digital health initiative — said in a news release. “Safe Health Systems, working with Mayo Clinic, will provide the suite of apps and services that universities, employers and organizations need to restart in-person activities and support new care models.”
The platform, called SAFE, combines several digital health apps — from provider services and artificial intelligence–based care automation to remote point-of-care diagnostics, according to the press release.
“The absence of remote testing is currently a limiting factor for digital and telehealth treatment of common low-complexity ailments (eg, sexually transmitted diseases, strep throat, urinary tract infections, upset stomach, flu, ear infection, etc),” the release states. “The current COVID-19 pandemic has amplified the need for remote diagnostic and digital care services.”
SAFE’s initial focus will be on enabling testing for COVID-19, STDs, and other common ailments, the news release said. “The platform is actively deployed for COVID-19 testing, linking patients, clinicians and test providers via HealthCheck, an advanced smartphone and desktop application. As COVID-19 vaccinations become available, the application will support vaccine workflow and verification.”
Jason A. Fortin, a Mayo Clinic spokesman, told Medscape Medical News that the HealthCheck app tracks which type of test was used to determine the COVID-19 status of an individual. This is key because some tests are more accurate than others. For example, polymerase chain reaction diagnostic tests, which require a lab, are more sensitive than rapid antigen tests, the kind used to test President Donald Trump recently.
“Clinical studies and IFU documentation determine test validation/accuracy,” Fortin said. “The validation process is not a function of Safe Health Systems. The platform allows for Safe Health Systems to work with customers [eg, companies or schools] to identify the most appropriate testing for their application. This flexibility allows for customization of the type of test and manufacturer to meet the user’s needs.”
The SAFE platform emerged from the Mayo Clinic and Arizona State University Alliance for Health Tech Accelerator program, an incubator for start-up technology companies. Mayo Clinic has since invested in Safe Health Systems.
The idea of a health or immunization passport has proved controversial in some European countries. Germany, for example, is considering the use of antibody tests manufactured by Swiss drugmaker Roche to test people for supposed immunity to COVID-19 until a safe and effective vaccine is developed.
In July, Germany announced a deal with Roche to buy millions of the blood tests, which have been approved by the US Food and Drug Administration. The plan was to use the results of these tests to certify people who tested positive for antibodies as immune to COVID-19. These individuals would be allowed to circulate more freely than those who tested negative.
However, German Health Minister Jens Spahn said that the country’s ethics council would have to provide advice to the government before it could implement this proposal. Spahn said there was concern about the impact on social cohesion of giving some people a passport to engage in activities that were forbidden to others.
Also, he said, there was a risk some people might purposely infect themselves in order to develop antibodies.
The regional government of Madrid, Spain’s capital, has moved closer to a health passport by proposing a pilot of so-called COVID cards that would identify holders as coronavirus-free. The card would allow those who had a positive COVID-19 antibody result to gain access to gyms, museums, bars, and the like.
However, experts have challenged the validity of basing freedom of movement on antibody tests. A large Spanish study, for example, showed that 14% of participants with antibodies had lost them when tested 3 months later.
Consequently, the World Health Organization has discouraged the use of immunity passports based on antibody tests.
It’s unclear whether COVID-19 testing — the kind of test the SAFE platform is storing the results of — is any better than antibody testing for identifying who could safely go back to work or back to school. Even daily testing of employees or students for COVID-19 might not pick up everyone with the disease.