Bad Actors Getting Your Health Data Is the FBI’s Latest Worry
In February 2015, the health insurer Anthem revealed that criminal hackers had gained access to the company's servers, exposing the personal information of nearly 79 million patients. It's the largest known healthcare breach in history.
FBI agents worry that the vast amounts of healthcare data being generated for precision medicine efforts could leave the U.S. vulnerable to cyber and biological attacks.
That year, the data of millions more would be compromised in one cyberattack after another on American insurers and other healthcare organizations. In fact, for the past several years, the number of reported data breaches has increased each year, from 199 in 2010 to 344 in 2017, according to a September 2018 analysis in the Journal of the American Medical Association.
The FBI's Edward You sees this as a worrying trend. He says hackers aren't just interested in your social security or credit card number. They're increasingly interested in stealing your medical information. Hackers can currently use this information to make fake identities, file fraudulent insurance claims, and order and sell expensive drugs and medical equipment. But beyond that, a new kind of cybersecurity threat is around the corner.
Mr. You and others worry that the vast amounts of healthcare data being generated for precision medicine efforts could leave the U.S. vulnerable to cyber and biological attacks. In the wrong hands, this data could be used to exploit or extort an individual, discriminate against certain groups of people, make targeted bioweapons, or give another country an economic advantage.
Precision medicine, of course, is the idea that medical treatments can be tailored to individuals based on their genetics, environment, lifestyle or other traits. But to do that requires collecting and analyzing huge quantities of health data from diverse populations. One research effort, called All of Us, launched by the U.S. National Institutes of Health last year, aims to collect genomic and other healthcare data from one million participants with the goal of advancing personalized medical care.
Other initiatives are underway by academic institutions and healthcare organizations. Electronic medical records, genetic tests, wearable health trackers, mobile apps, and social media are all sources of valuable healthcare data that a bad actor could potentially use to learn more about an individual or group of people.
"When you aggregate all of that data together, that becomes a very powerful profile of who you are," Mr. You says.
A supervisory special agent in the biological countermeasures unit within the FBI's weapons of mass destruction directorate, it's Mr. You's job to imagine worst-case bioterror scenarios and figure out how to prevent and prepare for them.
That used to mean focusing on threats like anthrax, Ebola, and smallpox—pathogens that could be used to intentionally infect people—"basically the dangerous bugs," as he puts it. In recent years, advances in gene editing and synthetic biology have given rise to fears that rogue, or even well-intentioned, scientists could create a virulent virus that's intentionally, or unintentionally, released outside the lab.
"If a foreign source, especially a criminal one, has your biological information, then they might have some particular insights into what your future medical needs might be and exploit that."
While Mr. You is still tracking those threats, he's been traveling around the country talking to scientists, lawyers, software engineers, cyber security professionals, government officials and CEOs about new security threats—those posed by genetic and other biological data.
Emerging threats
Mr. You says one possible situation he can imagine is the potential for nefarious actors to use an individual's sensitive medical information to extort or blackmail that person.
"If a foreign source, especially a criminal one, has your biological information, then they might have some particular insights into what your future medical needs might be and exploit that," he says. For instance, "what happens if you have a singular medical condition and an outside entity says they have a treatment for your condition?" You could get talked into paying a huge sum of money for a treatment that ends up being bogus.
Or what if hackers got a hold of a politician or high-profile CEO's health records? Say that person had a disease-causing genetic mutation that could affect their ability to carry out their job in the future and hackers threatened to expose that information. These scenarios may seem far-fetched, but Mr. You thinks they're becoming increasingly plausible.
On a wider scale, Kavita Berger, a scientist at Gryphon Scientific, a Washington, D.C.-area life sciences consulting firm, worries that data from different populations could be used to discriminate against certain groups of people, like minorities and immigrants.
For instance, the advocacy group Human Rights Watch in 2017 flagged a concerning trend in China's Xinjiang territory, a region with a history of government repression. Police there had purchased 12 DNA sequencers and were collecting and cataloging DNA samples from people to build a national database.
"The concern is that this particular province has a huge population of the Muslim minority in China," Ms. Berger says. "Now they have a really huge database of genetic sequences. You have to ask, why does a police station need 12 next-generation sequencers?"
Also alarming is the potential that large amounts of data from different groups of people could lead to customized bioweapons if that data ends up in the wrong hands.
Eleonore Pauwels, a research fellow on emerging cybertechnologies at United Nations University's Centre for Policy Research, says new insights gained from genomic and other data will give scientists a better understanding of how diseases occur and why certain people are more susceptible to certain diseases.
"As you get more and more knowledge about the genomic picture and how the microbiome and the immune system of different populations function, you could get a much deeper understanding about how you could target different populations for treatment but also how you could eventually target them with different forms of bioagents," Ms. Pauwels says.
Economic competitiveness
Another reason hackers might want to gain access to large genomic and other healthcare datasets is to give their country a leg up economically. Many large cyber-attacks on U.S. healthcare organizations have been tied to Chinese hacking groups.
"This is a biological space race and we just haven't woken up to the fact that we're in this race."
"It's becoming clear that China is increasingly interested in getting access to massive data sets that come from different countries," Ms. Pauwels says.
A year after U.S. President Barack Obama conceived of the Precision Medicine Initiative in 2015—later renamed All of Us—China followed suit, announcing the launch of a 15-year, $9 billion precision health effort aimed at turning China into a global leader in genomics.
Chinese genomics companies, too, are expanding their reach outside of Asia. One company, WuXi NextCODE, which has offices in Shanghai, Reykjavik, and Cambridge, Massachusetts, has built an extensive library of genomes from the U.S., China and Iceland, and is now setting its sights on Ireland.
Another Chinese company, BGI, has partnered with Children's Hospital of Philadelphia and Sinai Health System in Toronto, and also formed a collaboration with the Smithsonian Institute to sequence all species on the planet. BGI has built its own advanced genomic sequencing machines to compete with U.S.-based Illumina.
Mr. You says having access to all this data could lead to major breakthroughs in healthcare, such as new blockbuster drugs. "Whoever has the largest, most diverse dataset is truly going to win the day and come up with something very profitable," he says.
Some direct-to-consumer genetic testing companies with offices in the U.S., like Dante Labs, also use BGI to process customers' DNA.
Experts worry that China could race ahead the U.S. in precision medicine because of Chinese laws governing data sharing. Currently, China prohibits the exportation of genetic data without explicit permission from the government. Mr. You says this creates an asymmetry in data sharing between the U.S. and China.
"This is a biological space race and we just haven't woken up to the fact that we're in this race," he said in January at an American Society for Microbiology conference in Washington, D.C. "We don't have access to their data. There is absolutely no reciprocity."
Protecting your data
While Mr. You has been stressing the importance of data security to anyone who will listen, the National Academies of Sciences, Engineering, and Medicine, which makes scientific and policy recommendations on issues of national importance, has commissioned a study on "safeguarding the bioeconomy."
In the meantime, Ms. Berger says organizations that deal with people's health data should assess their security risks and identify potential vulnerabilities in their systems.
As for what individuals can do to protect themselves, she urges people to think about the different ways they're sharing healthcare data—such as via mobile health apps and wearables.
"Ask yourself, what's the benefit of sharing this? What are the potential consequences of sharing this?" she says.
Mr. You also cautions people to think twice before taking consumer DNA tests. They may seem harmless, he says, but at the end of the day, most people don't know where their genetic information is going. "If your genetic sequence is taken, once it's gone, it's gone. There's nothing you can do about it."
FDA, researchers work to make clinical trials more diverse
Nestled in a predominately Hispanic neighborhood, a new mural outside Guadalupe Centers Middle School in Kansas City, Missouri imparts a powerful message: “Clinical Research Needs Representation.” The colorful portraits painted above those words feature four cancer survivors of different racial and ethnic backgrounds. Two individuals identify as Hispanic, one as African American and another as Native American.
One of the patients depicted in the mural is Kim Jones, a 51-year-old African American breast cancer survivor since 2012. She advocated for an African American friend who participated in several clinical trials for ovarian cancer. Her friend was diagnosed in an advanced stage at age 26 but lived nine more years, thanks to the trials testing new therapeutics. “They are definitely giving people a longer, extended life and a better quality of life,” said Jones, who owns a nail salon. And that’s the message the mural aims to send to the community: Clinical trials need diverse participants.
While racial and ethnic minority groups represent almost half of the U.S. population, the lack of diversity in clinical trials poses serious challenges. Limited awareness and access impede equitable representation, which is necessary to prove the safety and effectiveness of medical interventions across different groups.
A Yale University study on clinical trial diversity published last year in BMJ Medicine found that while 81 percent of trials testing the new cancer drugs approved by the U.S. Food and Drug Administration between 2012 and 2017 included women, only 23 percent included older adults and 5 percent fairly included racial and ethnic minorities. “It’s both a public health and social justice issue,” said Jennifer E. Miller, an associate professor of medicine at Yale School of Medicine. “We need to know how medicines and vaccines work for all clinically distinct groups, not just healthy young White males.” A recent JAMA Oncology editorial stresses out the need for legislation that would require diversity action plans for certain types of trials.
Ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.--FDA Commissioner Robert M. Califf.
But change is on the horizon. Last April, the FDA issued a new draft guidance encouraging industry to find ways to revamp recruitment into clinical trials. The announcement, which expanded on previous efforts, called for including more participants from underrepresented racial and ethnic segments of the population.
“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” FDA commissioner Robert M. Califf, a physician, said in a statement. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics and clinical trials.”
Lola Fashoyin-Aje, associate director for Science and Policy to Address Disparities in the Oncology Center of Excellence at the FDA, said that the agency “has long held the view that clinical trial participants should reflect the clinical and demographic characteristics of the patients who will ultimately receive the drug once approved.” However, “numerous studies over many decades” have measured the extent of underrepresentation. One FDA analysis found that the proportion of White patients enrolled in U.S. clinical trials (88 percent) is much higher than their numbers in country's population. Meanwhile, the enrollment of African American and Native Hawaiian/American Indian and Alaskan Native patients is below their national numbers.
The FDA’s guidance is accelerating researchers’ efforts to be more inclusive of diverse groups in clinical trials, said Joyce Sackey, a clinical professor of medicine and associate dean at Stanford School of Medicine. Underrepresentation is “a huge issue,” she noted. Sackey is focusing on this in her role as the inaugural chief equity, diversity and inclusion officer at Stanford Medicine, which encompasses the medical school and two hospitals.
Until the early 1990s, Sackey pointed out, clinical trials were based on research that mainly included men, as investigators were concerned that women could become pregnant, which would affect the results. This has led to some unfortunate consequences, such as indications and dosages for drugs that cause more side effects in women due to biological differences. “We’ve made some progress in including women, but we have a long way to go in including people of different ethnic and racial groups,” she said.
A new mural outside Guadalupe Centers Middle School in Kansas City, Missouri, advocates for increasing diversity in clinical trials. Kim Jones, 51-year-old African American breast cancer survivor, is second on the left.
Artwork by Vania Soto. Photo by Megan Peters.
Among racial and ethnic minorities, distrust of clinical trials is deeply rooted in a history of medical racism. A prime example is the Tuskegee Study, a syphilis research experiment that started in 1932 and spanned 40 years, involving hundreds of Black men with low incomes without their informed consent. They were lured with inducements of free meals, health care and burial stipends to participate in the study undertaken by the U.S. Public Health Service and the Tuskegee Institute in Alabama.
By 1947, scientists had figured out that they could provide penicillin to help patients with syphilis, but leaders of the Tuskegee research failed to offer penicillin to their participants throughout the rest of the study, which lasted until 1972.
Opeyemi Olabisi, an assistant professor of medicine at Duke University Medical Center, aims to increase the participation of African Americans in clinical research. As a nephrologist and researcher, he is the principal investigator of a clinical trial focusing on the high rate of kidney disease fueled by two genetic variants of the apolipoprotein L1 (APOL1) gene in people of recent African ancestry. Individuals of this background are four times more likely to develop kidney failure than European Americans, with these two variants accounting for much of the excess risk, Olabisi noted.
The trial is part of an initiative, CARE and JUSTICE for APOL1-Mediated Kidney Disease, through which Olabisi hopes to diversify study participants. “We seek ways to engage African Americans by meeting folks in the community, providing accessible information and addressing structural hindrances that prevent them from participating in clinical trials,” Olabisi said. The researchers go to churches and community organizations to enroll people who do not visit academic medical centers, which typically lead clinical trials. Since last fall, the initiative has screened more than 250 African Americans in North Carolina for the genetic variants, he said.
Other key efforts are underway. “Breaking down barriers, including addressing access, awareness, discrimination and racism, and workforce diversity, are pivotal to increasing clinical trial participation in racial and ethnic minority groups,” said Joshua J. Joseph, assistant professor of medicine at the Ohio State University Wexner Medical Center. Along with the university’s colleges of medicine and nursing, researchers at the medical center partnered with the African American Male Wellness Agency, Genentech and Pfizer to host webinars soliciting solutions from almost 450 community members, civic representatives, health care providers, government organizations and biotechnology professionals in 25 states and five countries.
Their findings, published in February in the journal PLOS One, suggested that including incentives or compensation as part of the research budget at the institutional level may help resolve some issues that hinder racial and ethnic minorities from participating in clinical trials. Compared to other groups, more Blacks and Hispanics have jobs in service, production and transportation, the authors note. It can be difficult to get paid leave in these sectors, so employees often can’t join clinical trials during regular business hours. If more leaders of trials offer money for participating, that could make a difference.
Obstacles include geographic access, language and other communications issues, limited awareness of research options, cost and lack of trust.
Christopher Corsico, senior vice president of development at GSK, formerly GlaxoSmithKline, said the pharmaceutical company conducted a 17-year retrospective study on U.S. clinical trial diversity. “We are using epidemiology and patients most impacted by a particular disease as the foundation for all our enrollment guidance, including study diversity plans,” Corsico said. “We are also sharing our results and ideas across the pharmaceutical industry.”
Judy Sewards, vice president and head of clinical trial experience at Pfizer’s headquarters in New York, said the company has committed to achieving racially and ethnically diverse participation at or above U.S. census or disease prevalence levels (as appropriate) in all trials. “Today, barriers to clinical trial participation persist,” Sewards said. She noted that these obstacles include geographic access, language and other communications issues, limited awareness of research options, cost and lack of trust. “Addressing these challenges takes a village. All stakeholders must come together and work collaboratively to increase diversity in clinical trials.”
It takes a village indeed. Hope Krebill, executive director of the Masonic Cancer Alliance, the outreach network of the University of Kansas Cancer Center in Kansas City, which commissioned the mural, understood that well. So her team actively worked with their metaphorical “village.” “We partnered with the community to understand their concerns, knowledge and attitudes toward clinical trials and research,” said Krebill. “With that information, we created a clinical trials video and a social media campaign, and finally, the mural to encourage people to consider clinical trials as an option for care.”
Besides its encouraging imagery, the mural will also be informational. It will include a QR code that viewers can scan to find relevant clinical trials in their location, said Vania Soto, a Mexican artist who completed the rendition in late February. “I’m so honored to paint people that are survivors and are living proof that clinical trials worked for them,” she said.
Jones, the cancer survivor depicted in the mural, hopes the image will prompt people to feel more open to partaking in clinical trials. “Hopefully, it will encourage people to inquire about what they can do — how they can participate,” she said.
Send in the Robots: A Look into the Future of Firefighting
April in Paris stood still. Flames engulfed the beloved Notre Dame Cathedral as the world watched, horrified, in 2019. The worst looked inevitable when firefighters were forced to retreat from the out-of-control fire.
But the Paris Fire Brigade had an ace up their sleeve: Colossus, a firefighting robot. The seemingly indestructible tank-like machine ripped through the blaze with its motorized water cannon. It was able to put out flames in places that would have been deadly for firefighters.
Firefighting is entering a new era, driven by necessity. Conventional methods of managing fires have been no match for the fiercer, more expansive fires being triggered by climate change, urban sprawl, and susceptible wooded areas.
Robots have been a game-changer. Inspired by Paris, the Los Angeles Fire Department (LAFD) was the first in the U.S. to deploy a firefighting robot in 2021, the Thermite Robotics System 3 – RS3, for short.
RS3 is a 3,500-pound turbine on a crawler—the size of a Smart car—with a 36.8 horsepower engine that can go for 20 hours without refueling. It can plow through hazardous terrain, move cars from its path, and pull an 8,000-pound object from a fire.
All that while spurting 2,500 gallons of water per minute with a rear exhaust fan clearing the smoke. At a recent trade show, RS3 was billed as equivalent to 10 firefighters. The Los Angeles Times referred to it as “a droid on steroids.”
Robots such as the Thermite RS3 can plow through hazardous terrain and pull an 8,000-pound object from a fire.
Los Angeles Fire Department
The advantage of the robot is obvious. Operated remotely from a distance, it greatly reduces an emergency responder’s exposure to danger, says Wade White, assistant chief of the LAFD. The robot can be sent into airplane fires, nuclear reactors, hazardous areas with carcinogens (think East Palestine, Ohio), or buildings where a roof collapse is imminent.
Advances for firefighters are taking many other forms as well. Fibers have been developed that make the firefighter’s coat lighter and more protective from carcinogens. New wearable devices track firefighters’ biometrics in real time so commanders can monitor their heat stress and exertion levels. A sensor patch is in development which takes readings every four seconds to detect dangerous gases such as methane and carbon dioxide. A sonic fire extinguisher is being explored that uses low frequency soundwaves to remove oxygen from air molecules without unhealthy chemical compounds.
The demand for this technology is only increasing, especially with the recent rise in wildfires. In 2021, fires were responsible for 3,800 deaths and 14,700 injuries of civilians in this country. Last year, 68,988 wildfires burned down 7.6 million acres. Whether the next generation of firefighting can address these new challenges could depend on special cameras, robots of the aerial variety, AI and smart systems.
Fighting fire with cameras
Another key innovation for firefighters is a thermal imaging camera (TIC) that improves visibility through smoke. “At a fire, you might not see your hand in front of your face,” says White. “Using the TIC screen, you can find the door to get out safely or see a victim in the corner.” Since these cameras were introduced in the 1990s, the price has come down enough (from $10,000 or more to about $700) that every LAFD firefighter on duty has been carrying one since 2019, says White.
TICs are about the size of a cell phone. The camera can sense movement and body heat so it is ideal as a search tool for people trapped in buildings. If a firefighter has not moved in 30 seconds, the motion detector picks that up, too, and broadcasts a distress signal and directional information to others.
To enable firefighters to operate the camera hands-free, the newest TICs can attach inside a helmet. The firefighter sees the images inside their mask.
TICs also can be mounted on drones to get a bird’s-eye, 360 degree view of a disaster or scout for hot spots through the smoke. In addition, the camera can take photos to aid arson investigations or help determine the cause of a fire.
More help From above
Firefighters prefer the term “unmanned aerial systems” (UAS) to drones to differentiate them from military use.
A UAS carrying a camera can provide aerial scene monitoring and topography maps to help fire captains deploy resources more efficiently. At night, floodlights from the drone can illuminate the landscape for firefighters. They can drop off payloads of blankets, parachutes, life preservers or radio devices for stranded people to communicate, too. And like the robot, the UAS reduces risks for ground crews and helicopter pilots by limiting their contact with toxic fumes, hazardous chemicals, and explosive materials.
“The nice thing about drones is that they perform multiple missions at once,” says Sean Triplett, team lead of fire and aviation management, tools and technology at the Forest Service.
Experts predict we’ll see swarms of drones dropping water and fire retardant on burning buildings and forests in the near future.
The UAS is especially helpful during wildfires because it can track fires, get ahead of wind currents and warn firefighters of wind shifts in real time. The U.S. Forest Service also uses long endurance, solar-powered drones that can fly for up to 30 days at a time to detect early signs of wildfire. Wildfires are no longer seasonal in California – they are a year-long threat, notes Thanh Nguyen, fire captain at the Orange County Fire Authority.
In March, Nguyen’s crew deployed a drone to scope out a huge landslide following torrential rains in San Clemente, CA. Emergency responders used photos and videos from the drone to survey the evacuated area, enabling them to stay clear of ground on the hillside that was still sliding.
Improvements in drone batteries are enabling them to fly for longer with heavier payloads. Experts predict we’ll see swarms of drones dropping water and fire retardant on burning buildings and forests in the near future.
AI to the rescue
The biggest peril for a firefighter is often what they don’t see coming. Flashovers are a leading cause of firefighter deaths, for example. They occur when flammable materials in an enclosed area ignite almost instantaneously. Or dangerous backdrafts can happen when a firefighter opens a window or door; the air rushing in can ignite a fire without warning.
The Fire Fighting Technology Group at the National Institute of Standards and Technology (NIST) is developing tools and systems to predict these potentially lethal events with computer models and artificial intelligence.
Partnering with other institutions, NIST researchers developed the Flashover Prediction Neural Network (FlashNet) after looking at common house layouts and running sets of scenarios through a machine-learning model. In the lab, FlashNet was able to predict a flashover 30 seconds before it happened with 92.1% success. When ready for release, the technology will be bundled with sensors that are already installed in buildings, says Anthony Putorti, leader of the NIST group.
The NIST team also examined data from hundreds of backdrafts as a basis for a machine-learning model to predict them. In testing chambers the model predicted them correctly 70.8% of the time; accuracy increased to 82.4% when measures of backdrafts were taken in more positions at different heights in the chambers. Developers are working on how to integrate the AI into a small handheld device that can probe the air of a room through cracks around a door or through a created opening, Putorti says. This way, the air can be analyzed with the device to alert firefighters of any significant backdraft risk.
Early wildfire detection technologies based on AI are in the works, too. The Forest Service predicts the acreage burned each year during wildfires will more than triple in the next 80 years. By gathering information on historic fires, weather patterns, and topography, says White, AI can help firefighters manage wildfires before they grow out of control and create effective evacuation plans based on population data and fire patterns.
The future is connectivity
We are in our infancy with “smart firefighting,” says Casey Grant, executive director emeritus of the Fire Protection Research Foundation. Grant foresees a new era of cyber-physical systems for firefighters—a massive integration of wireless networks, advanced sensors, 3D simulations, and cloud services. To enhance teamwork, the system will connect all branches of emergency responders—fire, emergency medical services, law enforcement.
FirstNet (First Responder Network Authority) now provides a nationwide high-speed broadband network with 5G capabilities for first responders through a terrestrial cell network. Battling wildfires, however, the Forest Service needed an alternative because they don’t always have access to a power source. In 2022, they contracted with Aerostar for a high altitude balloon (60,000 feet up) that can extend cell phone power and LTE. “It puts a bubble of connectivity over the fire to hook in the internet,” Triplett explains.
A high altitude balloon, 60,000 feet high, can extend cell phone power and LTE, putting a "bubble" of internet connectivity over fires.
Courtesy of USDA Forest Service
Advances in harvesting, processing and delivering data will improve safety and decision-making for firefighters, Grant sums up. Smart systems may eventually calculate fire flow paths and make recommendations about the best ways to navigate specific fire conditions. NIST’s plan to combine FlashNet with sensors is one example.
The biggest challenge is developing firefighting technology that can work across multiple channels—federal, state, local and tribal systems as well as for fire, police and other emergency services— in any location, says Triplett. “When there’s a wildfire, there are no political boundaries,” he says. “All hands are on deck.”