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."
Story by Big Think
For most of history, artificial intelligence (AI) has been relegated almost entirely to the realm of science fiction. Then, in late 2022, it burst into reality — seemingly out of nowhere — with the popular launch of ChatGPT, the generative AI chatbot that solves tricky problems, designs rockets, has deep conversations with users, and even aces the Bar exam.
But the truth is that before ChatGPT nabbed the public’s attention, AI was already here, and it was doing more important things than writing essays for lazy college students. Case in point: It was key to saving the lives of tens of millions of people.
AI-designed mRNA vaccines
As Dave Johnson, chief data and AI officer at Moderna, told MIT Technology Review‘s In Machines We Trust podcast in 2022, AI was integral to creating the company’s highly effective mRNA vaccine against COVID. Moderna and Pfizer/BioNTech’s mRNA vaccines collectively saved between 15 and 20 million lives, according to one estimate from 2022.
Johnson described how AI was hard at work at Moderna, well before COVID arose to infect billions. The pharmaceutical company focuses on finding mRNA therapies to fight off infectious disease, treat cancer, or thwart genetic illness, among other medical applications. Messenger RNA molecules are essentially molecular instructions for cells that tell them how to create specific proteins, which do everything from fighting infection, to catalyzing reactions, to relaying cellular messages.
Johnson and his team put AI and automated robots to work making lots of different mRNAs for scientists to experiment with. Moderna quickly went from making about 30 per month to more than one thousand. They then created AI algorithms to optimize mRNA to maximize protein production in the body — more bang for the biological buck.
For Johnson and his team’s next trick, they used AI to automate science, itself. Once Moderna’s scientists have an mRNA to experiment with, they do pre-clinical tests in the lab. They then pore over reams of data to see which mRNAs could progress to the next stage: animal trials. This process is long, repetitive, and soul-sucking — ill-suited to a creative scientist but great for a mindless AI algorithm. With scientists’ input, models were made to automate this tedious process.
“We don’t think about AI in the context of replacing humans,” says Dave Johnson, chief data and AI officer at Moderna. “We always think about it in terms of this human-machine collaboration, because they’re good at different things. Humans are really good at creativity and flexibility and insight, whereas machines are really good at precision and giving the exact same result every single time and doing it at scale and speed.”
All these AI systems were in put in place over the past decade. Then COVID showed up. So when the genome sequence of the coronavirus was made public in January 2020, Moderna was off to the races pumping out and testing mRNAs that would tell cells how to manufacture the coronavirus’s spike protein so that the body’s immune system would recognize and destroy it. Within 42 days, the company had an mRNA vaccine ready to be tested in humans. It eventually went into hundreds of millions of arms.
Biotech harnesses the power of AI
Moderna is now turning its attention to other ailments that could be solved with mRNA, and the company is continuing to lean on AI. Scientists are still coming to Johnson with automation requests, which he happily obliges.
“We don’t think about AI in the context of replacing humans,” he told the Me, Myself, and AI podcast. “We always think about it in terms of this human-machine collaboration, because they’re good at different things. Humans are really good at creativity and flexibility and insight, whereas machines are really good at precision and giving the exact same result every single time and doing it at scale and speed.”
Moderna, which was founded as a “digital biotech,” is undoubtedly the poster child of AI use in mRNA vaccines. Moderna recently signed a deal with IBM to use the company’s quantum computers as well as its proprietary generative AI, MoLFormer.
Moderna’s success is encouraging other companies to follow its example. In January, BioNTech, which partnered with Pfizer to make the other highly effective mRNA vaccine against COVID, acquired the company InstaDeep for $440 million to implement its machine learning AI across its mRNA medicine platform. And in May, Chinese technology giant Baidu announced an AI tool that designs super-optimized mRNA sequences in minutes. A nearly countless number of mRNA molecules can code for the same protein, but some are more stable and result in the production of more proteins. Baidu’s AI, called “LinearDesign,” finds these mRNAs. The company licensed the tool to French pharmaceutical company Sanofi.
Writing in the journal Accounts of Chemical Research in late 2021, Sebastian M. Castillo-Hair and Georg Seelig, computer engineers who focus on synthetic biology at the University of Washington, forecast that AI machine learning models will further accelerate the biotechnology research process, putting mRNA medicine into overdrive to the benefit of all.
This article originally appeared on Big Think, home of the brightest minds and biggest ideas of all time.
Opioid prescription policies may hurt those in chronic pain
Tinu Abayomi-Paul works as a writer and activist, plus one unwanted job: Trying to fill her opioid prescription. She says that some pharmacists laugh and tell her that no one needs the amount of pain medication that she is seeking. Another pharmacist near her home in Venus, Tex., refused to fill more than seven days of a 30-day prescription.
To get a new prescription—partially filled opioid prescriptions can’t be dispensed later—Abayomi-Paul needed to return to her doctor’s office. But without her medication, she was having too much pain to travel there, much less return to the pharmacy. She rationed out the pills over several weeks, an agonizing compromise that left her unable to work, interact with her children, sleep restfully, or leave the house. “Don’t I deserve to do more than survive?” she says.
Abayomi-Paul’s pain results from a degenerative spine disorder, chronic lymphocytic leukemia, and more than a dozen other diagnoses and disabilities. She is part of a growing group of people with chronic pain who have been negatively impacted by the fallout from efforts to prevent opioid overdose deaths.
Guidelines for dispensing these pills are complicated because many opioids, like codeine, oxycodone, and morphine, are prescribed legally for pain. Yet, deaths from opioids have increased rapidly since 1999 and become a national emergency. Many of them, such as heroin, are used illegally. The CDC identified three surges in opioid use: an increase in opioid prescriptions in the ‘90s, a surge of heroin around 2010, and an influx of fentanyl and other powerful synthetic opioids in 2013.
As overdose deaths grew, so did public calls to address them, prompting the CDC to change its prescription guidelines in 2016. The new guidelines suggested limiting medication for acute pain to a seven-day supply, capping daily doses of morphine, and other restrictions. Some statistics suggest that these policies have worked; from 2016 to 2019, prescriptions for opiates fell 44 percent. Physicians also started progressively lowering opioid doses for patients, a practice called tapering. A study tracking nearly 100,000 Medicare subscribers on opioids found that about 13 percent of patients were tapering in 2012, and that number increased to about 23 percent by 2017.
But some physicians may be too aggressive with this tapering strategy. About one in four people had doses reduced by more than 10 percent per week, a rate faster than the CDC recommends. The approach left people like Abayomi-Paul without the medication they needed. Every year, Abayomi-Paul says, her prescriptions are harder to fill. David Brushwood, a pharmacy professor who specializes in policy and outcomes at the University of Florida in Gainesville, says opioid dosing isn’t one-size-fits-all. “Patients need to be taken care of individually, not based on what some government agency says they need,” he says.
‘This is not survivable’
Health policy and disability rights attorney Erin Gilmer advocated for people with pain, using her own experience with chronic pain and a host of medical conditions as a guidepost. She launched an advocacy website, Healthcare as a Human Right, and shared her struggles on Twitter: “This pain is more than anything I've endured before and I've already been through too much. Yet because it's not simply identified no one believes it's as bad as it is. This is not survivable.”
When her pain dramatically worsened midway through 2021, Gilmer’s posts grew ominous: “I keep thinking it can't possibly get worse but somehow every day is worse than the last.”
The CDC revised its guidelines in 2022 after criticisms that people with chronic pain were being undertreated, enduring dangerous withdrawal symptoms, and suffering psychological distress. (Long-term opioid use can cause physical dependency, an adaptive reaction that is different than the compulsive misuse associated with a substance use disorder.) It was too late for Gilmer. On July 7, 2021, the 38-year-old died by suicide.
Last August, an Ohio district court ruling set forth a new requirement for Walgreens, Walmart, and CVS pharmacists in two counties. These pharmacists must now document opioid prescriptions that are turned down, even for customers who have no previous purchases at that pharmacy, and they’re required to share this information with other locations in the same chain. None of the three pharmacies responded to an interview request from Leaps.org.
In a practice called red flagging, pharmacists may label a prescription suspicious for a variety of reasons, such as if a pharmacist observes an unusually high dose, a long distance from the patient’s home to the pharmacy, or cash payment. Pharmacists may question patients or prescribers to resolve red flags but, regardless of the explanation, they’re free to refuse to fill a prescription.
As the risk of litigation has grown, so has finger-pointing, says Seth Whitelaw, a compliance consultant at Whitelaw Compliance Group in West Chester, PA, who advises drug, medical device, and biotech companies. Drugmakers accused in National Prescription Opioid Litigation (NPOL), a complex set of thousands of cases on opioid epidemic deaths, which includes the Ohio district case, have argued that they shouldn’t be responsible for the large supply of opiates and overdose deaths. Yet, prosecutors alleged that these pharmaceutical companies hid addiction and overdose risks when labeling opioids, while distributors and pharmacists failed to identify suspicious orders or scripts.
Patients and pharmacists fear red flags
The requirements that pharmacists document prescriptions they refuse to fill so far only apply to two counties in Ohio. But Brushwood fears they will spread because of this precedent, and because there’s no way for pharmacists to predict what new legislation is on the way. “There is no definition of a red flag, there are no lists of red flags. There is no instruction on what to do when a red flag is detected. There’s no guidance on how to document red flags. It is a standardless responsibility,” Brushwood says. This adds trepidation for pharmacists—and more hoops to jump through for patients.
“I went into the doctor one day here and she said, ‘I'm going to stop prescribing opioids to all my patients effective immediately,” Nicolson says.
“We now have about a dozen studies that show that actually ripping somebody off their medication increases their risk of overdose and suicide by three to five times, destabilizes their health and mental health, often requires some hospitalization or emergency care, and can cause heart attacks,” says Kate Nicolson, founder of the National Pain Advocacy Center based in Boulder, Colorado. “It can kill people.” Nicolson was in pain for decades due to a surgical injury to the nerves leading to her spinal cord before surgeries fixed the problem.
Another issue is that primary care offices may view opioid use as a reason to turn down new patients. In a 2021 study, secret shoppers called primary care clinics in nine states, identifying themselves as long-term opioid users. When callers said their opioids were discontinued because their former physician retired, as opposed to an unspecified reason, they were more likely to be offered an appointment. Even so, more than 40 percent were refused an appointment. The study authors say their findings suggest that some physicians may try to avoid treating people who use opioids.
Abayomi-Paul says red flagging has changed how she fills prescriptions. “Once I go to one place, I try to [continue] going to that same place because of the amount of records that I have and making sure my medications don’t conflict,” Abayomi-Paul says.
Nicolson moved to Colorado from Washington D.C. in 2015, before the CDC issued its 2016 guidelines. When the guidelines came out, she found the change to be shockingly abrupt. “I went into the doctor one day here and she said, ‘I'm going to stop prescribing opioids to all my patients effective immediately.’” Since then, she’s spoken with dozens of patients who have been red-flagged or simply haven’t been able to access pain medication.
Despite her expertise, Nicolson isn’t positive she could successfully fill an opioid prescription today even if she needed one. At this point, she’s not sure exactly what various pharmacies would view as a red flag. And she’s not confident that these red flags even work. “You can have very legitimate reasons for being 50 miles away or having to go to multiple pharmacies, given that there are drug shortages now, as well as someone refusing to fill [a prescription.] It doesn't mean that you’re necessarily ‘drug seeking.’”
While there’s no easy solution. Whitelaw says clarifying the role of pharmacists and physicians in patient access to opioids could help people get the medication they need. He is seeking policy changes that focus on the needs of people in pain more than the number of prescriptions filled. He also advocates standardizing the definition of red flags and procedures for resolving them. Still, there will never be a single policy that can be applied to all people, explains Brushwood, the University of Florida professor. “You have to make a decision about each individual prescription.”