Federal class action lawsuit looms as genetics company searches for what went wrong; a reminder to clinical laboratories of the importance of protecting patient information
Several years ago, security experts warned that biotechnology and genomics company 23andMe, along with other similar genetics companies, would be attacked by hackers. Now those predictions appear to have come true, and it should be a cautionary tale for clinical laboratories. In an October 6 blog post, the genetic testing company confirmed that private information from thousands of its customers was exposed and may be being sold on the dark web.
According to Wired, “At least a million data points from 23andMe accounts appear to have been exposed on BreachForums.” BreachForums is an online forum where users can discuss internet hacking, cyberattacks, and database leaks, among other topics.
“Hackers posted an initial data sample on the platform BreachForums earlier this week, claiming that it contained one million data points exclusively about Ashkenazi Jews,” Wired reported, adding that “hundreds of thousands of users of Chinese descent” also appear to be impacted.
The leaked information included full names, dates of birth, sex, locations, photos, and both genetic and ancestry results, Bleeping Computer reported.
For its part, 23andMe acknowledges the data theft but claims “it does not see evidence that its systems have been breached,” according to Wired.
Anne Wojcicki (above) is the co-founder and CEO of genetics company 23andMe, which on October 24 told its customers in an email, “There was unauthorized access to one or more 23andMe accounts that were connected to you through DNA Relatives. As a result, the DNA Relatives profile information you provided in this feature was exposed to the threat actor.” Clinical laboratories must work to ensure their patient data is fully secured from similar cyber theft. (Photo copyright: TechCrunch.)
23andMe Claims Data Leak Not a Security Incident
The data leaked has been confirmed by 23andMe to be legitimate. “Threat actors used exposed credentials from other breaches [of other company’s security] to access 23andMe accounts and steal the sensitive data. Certain 23andMe customer profile information was compiled through access to individual 23andMe.com accounts,” a 23andMe spokesperson told Bleeping Computer.
However, according to the company, the leak does not appear to be a data security incident within the 23andMe systems. “The preliminary results of this investigation suggest that the login credentials used in these access attempts may have been gathered by a threat actor from data leaked during incidents involving other online platforms where users have recycled login credentials,” the spokesperson added.
What the genetics company has determined is that compromised accounts were from users choosing the DNA Relative feature on their website as a means to find and connect to individuals related to them. Additionally, “the number of accounts sold by the cybercriminal does not reflect the number of 23andMe accounts breached using exposed credentials,” Bleeping Computer noted.
Price of Private Information
Following the 23andMe data leak, the private genetic information was quickly available online … for a price.
“On October 4, the threat actor offered to sell data profiles in bulk for $1-$10 per 23andMe account, depending on how many were purchased,” Bleeping Computer reported.
Stolen medical records are becoming hotter than credit card information, the experts say. “Stolen records sell for as much as $1,000 each,” according to credit rating agency Experian, Bleeping Computer noted.
Clinical laboratory managers and pathologists should take note of the value that the dark web places on the medical records of a patient, compared to the credit card numbers of the same individual. From this perspective, hacking a medical laboratory to steal patient health data can be much more lucrative than hacking the credit card data from a retailer.
“Victims of the breach are now at increased risk of fraud and identity theft, and have suffered damages in the form of invasion of privacy, lost time and out-of-pocket expenses incurred responding to the breach, diminished value of their personal information, and lost benefit of the bargain with 23andMe,” according to court documents.
“The lawsuit brings claims of negligence, breach of implied contract, invasion of privacy/intrusion upon seclusion, unjust enrichment, and declaratory judgment,” Bloomberg Law noted. Additionally, the claim states that 23andMe “failed to provide prompt and adequate notice of the incident.”
Plaintiffs are “seeking actual damages, compensatory damages, statutory damages, punitive damages, lifetime credit-monitoring services, restitution, disgorgement, injunctive relief, attorneys’ fees and costs, and pre-and post-judgment interest,” Bloomberg Law reported.
Preventing Future Data Leaks
Years of experts warning genetics companies like 23andMe that they need more strict data security have proven to be true. “This incident really highlights the risks associated with DNA databases,” Brett Callow, a threat analyst at data security firm Emsisoft, told Wired. “The fact that accounts had reportedly opted into the ‘DNA Relatives’ feature is particularly concerning as it could potentially result in extremely sensitive information becoming public.”
“Callow notes that the situation raises broader questions about keeping sensitive genetic information safe and the risks of making it available in services that are designed like social networks to facilitate sharing. With such platforms come all of the data privacy and security issues that have plagued traditional social networks, including issues related to data centralization and scraping,” Wired noted.
Clinical laboratory databases are full of protected health information (PHI). Wise lab managers will work to ensure that their medical lab’s patient data is secure from today’s cyberthreats.
In “World’s Largest Pathologists Association Discloses Credit Card Incident,” Bleeping Computer, an information security and technology news publication, reported that on March 11 of this year, ASCP employees discovered their system had been hacked. They discerned that between March 3, 2020, and November 6, 2020, the attackers had access to personal information being entered on the ASCP website.
Bleeping Computer noted that “[the ASCP’s] member list includes over 100,000 medical laboratory professionals, clinical and anatomic pathologists, residents, and students.”
In a statement, the ASCP said, “We have recently been informed that our e-commerce website was the target of a cybersecurity attack that, for a limited time period, potentially exposed payment card data as it was entered on our website.”
The information that may have been stolen includes data pertaining to individual credit cards, names, credit or debit card numbers, expiration dates, and security codes (CVV) associated with the cards.
“We engaged external forensic investigators and data privacy professionals and conducted a thorough investigation into the incident,” the ASCP said in the statement.
What Type of Cyberattack?
Evidence collected regarding the ASCP data breach indicates the attack was part of a web-skimming assault. This involves installing malicious software, such as Magecart, onto an e-commerce website. The software acts like a credit card skimmer enabling hackers to steal the payment and personal information of customers who are actively inputting data on the attacked website. The data is then sent to remote servers where it is used for identity theft or sold to others.
ASCP says it does not permanently store any of its customers’ payment card data on its servers, Bleeping Computer reported, which greatly reduces the potential risk of data exposure. In addition, the ASCP has implemented extra security measures to prevent similar incidents from happening in the future.
“We resolved the issue that led to the potential exposure on the website. We implemented additional security safeguards to protect against future intrusions. We continue ongoing intensive monitoring of our website, to ensure that it exceeds industry standards to be secure of any malicious activity,” the ASCP said in a statement, Bleeping Computer reported.
Federal Rules and Regulations Concerning HIPAA and PHI
The ASCP stated they have no evidence that any customer data was misused after the incident occurred. As of May 14, the organization has not made an official, public statement regarding the situation on their website, but affected individuals and jurisdictions were sent letters to inform them of the data breach.
With over 130,000 current members, Chicago-based ASCP is the largest professional organization for pathologists and clinical laboratory professionals in the world. The organization did not respond to Dark Daily’s inquiries regarding the data breach.
Notify affected individuals within 60 days of the discovery of the breach. Notification should include a brief description of the breach, the types of information that may have been compromised, steps affected individuals should take to protect themselves from potential harm, and a description of what the organization is doing to investigate the breach, mitigate the harm, and prevent further breaches.
Hacked entity must inform the Secretary of Health and Human Services (HHS) within 60 days of the breach discovery if 500 or more individuals were affected. For breaches affecting less than 500 people, the breached entity may notify the Secretary of such breaches on an annual basis.
For breaches affecting more than 500 individuals, the hacked entity must also provide a notification to prominent media outlets, typically via a press release, that serve the state or jurisdiction.
This breach of credit card information belonging to a sizeable number of pathologists and clinical laboratory professionals using the ASCP website should be a warning to all clinical laboratories and anatomic pathology groups—along with colleges, societies, and associations—that their websites and digital systems can be attacked at any time. As well, clinical laboratory and pathology professionals should be on the alert and take all necessary precautions to minimize the possibility of data breaches.
Clinical laboratories need to understand how their patients’ protected health information is being used and secured by vendors to avert data breaches and HHS penalties
Most readers of The Dark Report, the sister publication to the Dark Daily, are aware that more than 24-million clinical laboratory patients had their protected health information (PHI) stolen during several recent data breaches involving multiple medical laboratory companies.
The first public statements made by clinical lab companies
about breaches of protected health information were issued in June.
Collectively, the following three lab companies announced that the data of more
than 20 million patients was compromised:
Until recently, any violation of HIPAA could draw down enormous fines—called Civil Money Penalties (CMPs)—by the US Department of Health and Human Services (HHS). Fines could reach $1.5 million annually across four categories, or tiers, of violations, depending on HHS’ determination as to the “level of culpability” of the violator. Those categories and min/max fines include:
No Knowledge, $100-$50,000 fine, $1.5 mil annual
Reasonable Cause, $1,000-$50,000 fine, $1.5 mil
In the notice, HHS stated, “the Department recognized that
section 13410(d) contained apparently inconsistent language (i.e., its
reference to two penalty tiers ‘for each violation,’ each of which provided a
penalty amount ‘for all such violations’ of an identical requirement or
prohibition in a calendar year). To resolve this inconsistency, with the
exception of violations due to willful neglect that are not timely corrected,
the [interim final rule] adopted a range of penalty amounts between the minimum
given in one tier and the maximum given in the second tier for each violation
and adopted the amount of $1.5 million as the limit for all violations of an
identical provision of the HIPAA rules in a calendar year.”
Modern Healthcare reports that “organizations that have taken measures to meet HIPAA’s requirements will face a much smaller maximum penalty than those who are found neglectful.”
Thus, the new HHS guidelines will be of interest to clinical
laboratories, which must ensure the privacy of patients’ PHI, including being
keenly aware of how vendor business associates are handling their patients’
Did HHS Go Too Far?
Some experts, however, wonder if HHS went too far in
reducing annual penalties providers may owe. Could lower annual CMP caps cause
organizations to relax strict PHI policies? Some privacy authorities urge
caution and raise concern about how incentives may be perceived by providers
“HHS is adopting a much lower annual cap for all violations except those due to willful neglect, which means significantly lower penalties for large breaches and for ongoing persistent violations of the rules,” Deven McGraw, Chief Regulatory Officer at Citizen Corporation and former Deputy Director Health Information Privacy for HHS’ Office for Civil Rights, told FierceHealthcare.
“Arguably,” she continued, “the incentive to fix these
persistent failures is much less because the potential fines for failing to do
so will not be very large. Same is true for large breaches—if you breach 10
records, at a minimum penalty of $1,000 for a breach due to reasonable cause,
your fine would be $100,000, which is the annual cap.”
New Annual Limits Recognize ‘Unintentional’ Violations
But not all experts agree. Prior to HHS’ announcement,
minimum to maximum penalty violations were the same as noted in the tiers
above. The annual limits ($1.5 million), however, were the same for each of the
Matthew Fisher, Partner at Mirick O’Connell and Chair of the Worcester, Mass. firm’s health law group, says the new penalty structure “is arguably good in terms of aligning potential penalties with the level of culpability.”
“If a violation was clearly unintentional and without
knowledge, why should a potentially massive fine follow? While the discretion
existed, the interpretation will now be binding and remove the potential
uncertainty,” he told FierceHealthcare.
Advice for Clinical Laboratories
Labs are advised to develop appropriate procedures to
safeguard their patients’ PHI under federal and state laws. And this includes
knowing how vendors handle PHI.
“Every lab should be proactive and do a review to understand
each vendor’s policies, procedures, training, and response in the event of a
Giszczak, Data Privacy and Cybersecurity Attorney and Chair of the
Litigation Department at McDonald
Hopkins in Bloomfield Hills, Mich., told The
Dark Report (TDR).
“By being prepared, clinical laboratories can save
themselves many headaches,” he said. “Ultimately, these proactive steps may
help laboratories save time, money, and costly bad publicity.”
Following that advice, along with understanding the new HHS notice,
will help medical laboratory managers ensure the privacy and security of their