Last week, Oakland University’s president Ora Hirsch Pescovitz sent out her usual email updating students on the college. This time, it included a link that pointed to a page explaining what to expect for the fall semester. The web page mentioned something called a BioButton. Students would be required to document their symptoms daily in a symptom-checking app and wear this thumbprint-size silicon patch that would record body temperature, ambient temperature, respiratory rate, heart rate, activity level, and sleep. It would also detect if you came into contact with someone with COVID-19.
There were certain things about the BioButton that concerned Tyler Dixon, a resident assistant at the Michigan-based Oakland University who will be a senior in the fall. He understood that the school was instituting this program as a public health measure, to ensure that students would be safe when they returned to school. But this BioButton would be tracking a lot of data, and he was concerned about who would be accessing it. He and his friends discussed the issue, and Dixon decided to launch a petition asking that Oakland University make the BioButton optional.
“I did it thinking it would get 200 signatures and student congress would see it and bring the issue to [school administrators], and then it blew up—it got 2,500 signatures,” says Dixon, about 13% of the school’s student body.
Oakland University took notice immediately and reversed course on the decision to mandate that students wear the BioButton. It will now be optional.
The university’s reversal on the BioButton highlights the complications of launching an effective public health program inside of a small community like a school. Amid rising case numbers and a dearth of national policy on when and how schools should open, it can be difficult to know which institutions and what information to rely on. In addition, an ongoing infodemic of misinformation, conspiracy theories, and lack of clear, factually based direction from the highest levels of government has perpetuated an underlying feeling of distrust the runs deep among Americans.
Dixon says that the university president’s initial message about plans for the fall was very atypical. First of all, Pescovitz had previously been hosting updates via 30-minute videos sessions. The school also made transcripts of the video available for students and held student concern forums, where students could air their grievances. So this message, posted online without much detail, was unusual. Students were left to research the BioButton and the company that makes it, BioIntellisense, on their own.
That research is where things got concerning, at least for Dixon and his friends. The university had said the data would only be available to the user, but Dixon had read that contact tracing would be part of it. “It was confusing,” he says. If contact tracing was part of the BioButton, he believed that there must be some sort of location tracking. His friends have been going to protests for Black Lives Matter and often left their phones at home for fear that they could be tracked or identified. They wondered who was accessing the BioButton data for contact tracing—and what would they do with it?
“I’m not some anti-masker,” he says. Still, he was worried about the implications of this biodata-tracking wearable.
BioIntelliSense CEO James Mault says that what happened at Oakland University was a big failure of communication. “No one had real information about what this program was going to be,” he says. The BioButton does register a lot of personal health data, but Mault insists that the only person who has access to any of it is the person wearing the button.
Tracing the BioButton’s origins
The BioButton got its start as the BioSticker, a 30-day wearable that monitors vital signs for patients remotely. Mault, who worked in intensive care as a cardiothoracic surgeon, designed the device so that doctors can keep an eye on patients who are newly discharged from the hospital in case they relapse.
Mault knows personally the worries doctors have when sending a patient home after having a serious health issue, and COVID-19 has been a brutal example of what those fears can look like when realized. In New York, during the pandemic, some severely ill patients who were believed to be on the mend were sent to a hotel to recover—and died. Mault has spent the balance of his career making the kind of technology he was able to use in operating theaters and intensive care units available at home to avoid the kinds of fatal issues that can arise once patients leave the hospital.
He started BioIntelliSense in 2018, and the company’s first device, the BioSticker, received FDA approval in January 2020. BioIntelliSense quickly struck up a series of relationships with hospital systems. Then COVID-19 struck.
Mault says that employers and universities started getting in touch about using the BioSticker to monitor employees for symptoms. It was this interest that led to the development of the BioButton, a three-month wearable that tracks for certain vital signs in order to screen for COVID-19 or other potential illnesses. It acts as a complement to a symptom-tracking mobile app, where individuals can self-report how they’re feeling that day.
“We have 1,440 temperature measurements a day,” Mault says. “We can see stuff that you just wouldn’t see from taking your temperature twice a day.” A person’s temperature can fluctuate during the day under normal circumstances. Rather than checking your temperature once, the BioButton can follow your temperature over time and can know both your baseline temperature and whether it’s spiking abnormally. It can also register other symptoms over time and that collective data may better indicate whether a person is sick.
For example, the BioButton can cut down on the amount of time a person might have to stay in quarantine. In the Cayman Islands, where visitors are required to wear the BioButton, travelers only have to quarantine for seven days before they’re free to move around the island. Mault says that’s because the BioButton can tell within a week if there are irregularities that might indicate COVID-19.
Fears over data privacy
Mault says he is keenly aware of the privacy risks involved in making medical products like the BioButton. The device only remits health data back to the user and no one else has access—not a school, not an employer. When the platform determines that a person should not come into school or work, the system alerts an administrator. They are only told that a person cannot come in, but they are not told why, says Mault. Of course, whoever the administrator is can make a reasonable assumption that a person marked as ill likely has COVID-19. Even so, only the wearer ever gets access to symptom level data. The wearer must also take steps to clear their status by seeking follow-up care with a doctor, either one of their choosing or through the school.
As far as contact tracing is concerned, says Mault, the BioButton only detects proximity to another BioButton. It does not have GPS location tracking. It only knows when it has been close to another BioButton that is marked for COVID-19 and at that point it informs the wearer that they have been in contact with someone with COVID-19. It does not tell them who.
Still, Mault says he understands the concern. Ideally, there would be a third party, like a telehealth provider, that the school contracts with who would manage the student’s care if they are flagged for COVID-19 symptoms. In such a scenario, the app would direct a student with potential symptoms directly to a doctor over video and either clear the student to come back to school or manage next steps. He says his company is working on introducing a telehealth partner to further reduce concern about sharing data with the university. But he also thinks the way that programs like the BioButton are introduced is important in order to get everyone on board. If people are not adequately educated on what a public health initiative with health tracking involves, then they won’t do it. If they don’t do it, then there’s risk that it won’t work to mitigate transmission.
“The most successful countries right now who have COVID reasonably under control have accomplished that by a pretty consistent practice throughout the country where everybody is willing to participate according to the recommendations and rules,” says Mault. Here in the United States, he says, we know very clearly that wearing a mask is undeniably a smart thing to do and dramatically reduces the spread of COVID-19. Yet, he says, there are a lot of states that have struggled to make masks a mandate. He thinks misinformation, poor communication, and a lack of transparency are largely to blame.
“The sad reality is no one knows what to believe—there is so much misinformation and there is so much vitriol,” he says.