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Clinical Laboratories and Pathology Groups

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American Society for Clinical Pathology Website Was Hacked Last Year, Possibly Exposing Credit Card Information of Members and Online Shoppers

Thousands of pathologists and medical technologists may have had their private data stolen, though ASCP investigators did not confirm this as having happened

For a “limited time period” in 2020, the American Society for Clinical Pathology (ASCP) was the target of a cyberattack that “potentially exposed payment card data as it was

being entered” on the ASCP website, according to a letter sent by McDonald Hopkins PLC to then Attorney General of the New Hampshire Department of Justice (DOJ) Gordon MacDonald.

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.

Peter-Blum-Group-Product-Manager-Google
In an interview with TechRepublic, Peter Blum (above), Group Product Manager at Google, discussed steps companies can take to proactively manage the threat of Magecart cyberattacks. “The best defense against Magecart attacks is preventing access,” Blum said. “Online companies need a solution that intercepts all of the API [application programming interface] calls your website makes to the browser and blocks access to sensitive data you have not previously authorized. This prevents any malicious script, or any non-critical third-party script, from gaining access to information your customers enter on your website. This same system should also have a monitoring component to alert companies when a third-party attempts to access sensitive information.” (Photo copyright: LinkedIn.)

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.

Although no reported violations under the Health Insurance Portability and Accountability Act (HIPAA) occurred in this ASCP data breach, it should be noted that there are rules under HIPAA for data breaches where Protected Health Information (PHI) may have been compromised.

Under the HIPAA Breach Notification Rule, entities that were hacked must perform the following steps:

  • 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.

—JP Schlingman

Related Information:

World’s Largest Pathologists Association Discloses Card Incident

American Society for Clinical Pathology—Incident Notification

ASCP Disclosed Payment Card Web Skimming Incident

Magecart Attack: What It is, How it Works, and How to Prevent It

What is Magecart? How This Hacker Group Steals Payment Card Data

A Deep Dive into Magecart: What Is Magecart?

Compliance Perspectives: State Enforcement Raises Liability Risks of Data Breaches

Three Federal Agencies Warn Healthcare Providers of Pending Ransomware Attacks; Clinical Laboratories Advised to Assess Their Cyberdefenses

University of California San Diego Researchers Demonstrates How Easily Medical Laboratory Systems and Devices Can Be Compromised, Putting Patient Lives at Risk

WannaCry Ransomware Holds Critical Data Hostage Worldwide, Including UK’s National Health Service and Russia’s Interior Ministry

UK’s NHS Will Use Amazon Alexa to Deliver Official Health Advice to Patients in the United Kingdom

Since Alexa is now programed to be compliant with HIPAA privacy rules, it’s likely similar voice assistance technologies will soon become available in US healthcare as well

Shortages of physicians and other types of caregivers—including histopathologists and pathology laboratory workers—in the United Kingdom (UK) has the UK’s National Health Service (NHS) seeking alternate ways to get patients needed health and medical information. This has prompted a partnership with Amazon to use the Alexa virtual assistant to answer patients healthcare inquiries.

Here in the United States, pathologists and clinical laboratory executives should take the time to understand this development. The fact that the NHS is willing to use a device like Alexa to help it maintain access to services expected by patients in the United Kingdom shows how rapidly the concept of “virtual clinical care” is moving to become mainstream.

If the NHS can make it work in a health system serving 66-million people, it can be expected that health insurers, hospitals, and physicians in the United States will follow that example and deploy similar virtual health services to their patients.

For these reasons, all clinical laboratories and anatomic pathology groups will want to develop a strategy as to how their organizations will interact with virtual health services and how their labs will want to deploy similar virtual patient information services.

Critical Shortages in Healthcare Services

While virtual assistants have been answering commonly-asked health questions by mining popular responses on the Internet for some time, this new agreement allows Alexa to provide government-endorsed medical advice drawn from the NHS website.

By doing this, the NHS hopes to reduce the burden on healthcare workers by making it easier for UK patients to access health information and receive answers to commonly-asked health questions directly from their homes, GeekWire reported. 

“The public needs to be able to get reliable information about their health easily and in ways they actually use. By working closely with Amazon and other tech companies, big and small, we can ensure that the millions of users looking for health information every day can get simple, validated advice at the touch of a button or voice command,” Matthew Gould, CEO of NHSX, a division of the NHS that focuses on digital initiatives, told GeekWire

The Verge reported that when the British government officially announced the partnership in a July press release, the sample questions that Alexa could answer included:

  • Alexa, how do I treat a migraine?
  • Alexa, what are the symptoms of the flu?
  • Alexa, what are the symptoms of chickenpox?

“We want to empower every patient to take better control of their healthcare and technology like this is a great example of how people can access reliable, world-leading NHS advice from the comfort of their home, reducing the pressure on our hardworking GPs (General Practitioners) and pharmacists,” said Matt Hancock, Secretary of State for Health and Social Care, in the press release.

MD Connect notes that the NHS provides healthcare services free of charge to more than 66-million individuals residing in the UK. With 1.2 million employees, the NHS is the largest employer in Europe, according to The Economist. That article also stated that the biggest problem facing the NHS is a staff shortage, citing research conducted by three independent organizations:

Their findings indicate “that NHS hospitals, mental-health providers, and community services have 100,000 vacancies, and that there are another 110,000 gaps in adult social care. If things stay on their current trajectory, the think-tanks predict that there will be 250,000 NHS vacancies in a decade,” The Economist reported.

UK’s Matt Hancock, Secretary of State for Health and Social Care (above), defends the NHS’ partnership with Amazon Alexa, saying millions already use the smart speaker for medical advice and it’s important the health service uses the “best of modern technology.” Click here to watch the video. (Video and caption copyright: Sky News.)

“This idea is certainly interesting and it has the potential to help some patients work out what kind of care they need before considering whether to seek face-to-face medical help, especially for minor ailments that rarely need a GP appointment, such as coughs and colds that can be safely treated at home,” Professor Helen Stokes-Lampard, Chairman at the Royal College of General Practitioners, and Chair of the Board Of Directors/Trustees at National Academy of Social Prescribing, told Sky News.

“However,” she continued, “it is vital that independent research is done to ensure that the advice given is safe, otherwise it could prevent people seeking proper medical help and create even more pressure on our overstretched GP service.”

Amazon has assured consumers that all data obtained by Alexa through the NHS partnership will be encrypted to ensure privacy and security, MD Connect notes. Amazon also promised that the personal information will not be shared or sold to third parties.

Alexa Now HIPAA Compliant in the US

This new agreement with the UK follows the announcement in April of a new Alexa Skills Kit that “enables select Covered Entities and their Business Associates, subject to the US Health Insurance Portability and Accountability Act of 1996 (HIPAA), to build Alexa skills that transmit and receive protected health information (PHI) as part of an invite-only program. Six new Alexa healthcare skills from industry-leading healthcare providers, payors, pharmacy benefit managers, and digital health coaching companies are now operating in our HIPAA-eligible environment.”

Developers of voice assistance technologies can freely use these Alexa skills, which are “designed to help customers manage a variety of healthcare needs at home simply using voice—whether it’s booking a medical appointment, accessing hospital post-discharge instructions, checking on the status of a prescription delivery, and more,” an Amazon Developer Alexa blog states.

The blog lists the HIPAA-compliant Alexa skills as:

  • Express Scripts: Members can check the status of a home delivery prescription and can request Alexa notifications when their prescription orders are shipped.
  • Cigna Health Today by Cigna (NYSE:CI): Eligible employees with one of Cigna’s large national accounts can now manage their health improvement goals and increase opportunities for earning personalized wellness incentives.
  • My Children’s Enhanced Recovery After Surgery (ERAS) (by Boston Children’s Hospital: Parents and caregivers of children in the ERAS program can provide their care teams updates on recovery progress and receive information regarding their post-op appointments.
  • Swedish Health Connect by Providence St. Joseph Health, a healthcare system with 51 hospitals across seven states and 829 clinics: Customers can find an urgent care center near them and schedule a same-day appointment.
  • Atrium Health, a healthcare system with more than 40 hospitals and 900 care locations throughout North and South Carolina and Georgia: Customers in North and South Carolina can find an urgent care location near them and schedule a same-day appointment.
  • Livongo, a digital health company that creates new and different experiences for people with chronic conditions: Members can query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.

HIPAA Journal notes: “This is not the first time that Alexa skills have been developed, but a stumbling block has been the requirements of HIPAA Privacy Rules, which limit the use of voice technology with protected health information. Now, thanks to HIPAA compliant data transfers, the voice assistant can be used by a select group of healthcare organizations to communicate PHI without violating the HIPAA Privacy Rule.”

Steady increases associated with the costs of medical care combined with a shortage of healthcare professionals on both continents are driving trends that motivate government health programs and providers to experiment with non-traditional ways to interact with patients.

New digital and Artificial Intelligence (AI) tools like Alexa may continue to emerge as methods for providing care—including clinical laboratory and pathology advice—to healthcare consumers.

—JP Schlingman

Related Information:

“Alexa, How Do I Treat a Migraine?” Amazon and NHS Unveil Partnership

Amazon’s Alexa Will Deliver NHS Medical Advice in the UK

NHS Health Information Available Through Amazon’s Alexa

UK’s National Health Service Taps Amazon’s Alexa to Field Common Medical Questions

What Happens When Amazon Alexa Gives Health Advice?

Alexa, Where Are the Legal Limits on What Amazon Can Do with My Health Data?

Amazon Alexa Offering NHS Health Advice

A Shortage of Staff Is the Biggest Problem Facing the NHS

Need Quick Medical Advice in Britain? Ask Alexa

Alexa Blogs: Introducing New Alexa Healthcare Skills

Amazon Announces 6 New HIPAA Compliant Alexa Skills

Amazon Alexa Is Now HIPAA-Compliant: Tech Giant Says Health Data Can Now Be Accessed Securely

Can Artificial Intelligence Diagnose Skin Cancers More Accurately than Anatomic Pathologists? Heidelberg University Researchers Say “Yes”

Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, But Which Will Impact Clinical Laboratories the Most?

As Primary Care Providers and Health Insurers Embrace Telehealth, How Will Clinical Laboratories Provide Medical Lab Testing Services?

VA Engages Private Sector Companies in Major Telehealth Initiative to Bring Critical Healthcare Services to Thousands of Veterans Living in Remote Areas

HHS Announces Culpability Limits for HIPAA Violations, Drops Annual Fines Owed by Providers

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:

In the eight weeks that followed, additional medical laboratory companies publicly disclosed breaches of their patient data, including:

What all these clinical lab companies had in common was that they had contracted with American Medical Collection Agency (AMCA) to process lab test claims. AMCA is where the data breaches originated.

Under the rules established by the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996, responsibility for the security of patient PHI falls to covered entities and business associates. This includes healthcare providers, health plans, and healthcare clearinghouses, such as AMCA. For clinical laboratories, this also includes vendors who receive patients’ PHI to complete their service contracts.

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 limit.
  • Reasonable Cause, $1,000-$50,000 fine, $1.5 mil annual limit.
  • Willful Neglect-Corrected, $10,000-$50,000, $1.5 annual limit.
  • Willful Neglect-Not Corrected, $50,000-$50,000, $1.5 annual limit.

Earlier this year, HHS released a “Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties.” In it, HHS revised its interpretation of the law and reduced CMPs, while more clearly defining how provider culpability ties to the ultimate amount of the fines:

  • No Knowledge, $100-$50,000 fine, $25,000 annual limit.
  • Reasonable Cause, $1,000-$50,000 fine, $100,000 annual limit.
  • Willful Neglect-Corrected, $10,000-$50,000, $250,000 annual limit.
  • Willful Neglect-Not Corrected, $50,000-$50,000, $1.5 annual limit

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’ data.

In an exclusive interview with The Dark Report, James Giszczak (above), Data Privacy and Cybersecurity Attorney and Chair of the Litigation Department at McDonald Hopkins, said two important steps clinical laboratories must take include, “ensuring that your vendor has appropriate insurance policies in place that cover PHI breaches, and confirming that vendors comply with laws governing the protection of patients’ information.” To do that, he says, every lab needs to ensure that all critical provisions are covered in each contract it has with each vendor. (Photo copyright: Institute of Continuing Legal Education.)

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 and others.

“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 four tiers.

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 breach,” James 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 client’s PHI.

—Donna Marie Pocius

Related Information:

HHS Implements HIPAA Fine Caps Based on Level of Culpability

Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties

HHS Moves to Reduce HIPAA Fines Lowering the Cap More Than $M for Some Violations

HHS to Cap HIPAA Fines Based on “Culpability”

Labs Should Heed Lessons from Huge Data Breach

Late-Breaking Lab News: Add Eight More Laboratories to the List of Lab Companies Whose Patient Data Were Breached

DOJ Pursues Organizations That Falsely Claim Compliance with Medicare’s EHR Incentive Programs

Clinical laboratories that interface with hospital EHR systems under scrutiny by the DOJ could be drawn into the investigations

Officials at the federal US Department of Justice (DOJ) continue to pursue fraud cases involving health systems that allegedly have falsely attested to complying with the Medicare and Medicaid electronic health record (EHR) adoption incentive programs (now known as the Promoting Interoperability Programs).

This is important for clinical laboratory leaders to watch, because medical labs often interface with hospital EHRs to exchange vital patient data, a key component of complying with Medicare’s EHR incentive programs. If claims of interoperability are shown to be false, could labs engaged with those hospital systems under scrutiny be drawn into the DOJ’s investigations?

Violating the False Claims Act

In May, Coffey Health System (CHS), which includes Coffey County Hospital, a 25-bed critical access hospital located in Burlington, Kan., agreed to pay the US government a total of $250,000 to settle a claim that it violated the False Claims Act.

CHS’ former CIO filed the qui tam (aka, whistleblower) lawsuit, which allows individuals to sue on behalf of the government and share in monetary recovery. He alleged that CHS provided false information to the government about being in compliance with security standards to receive incentive payments under the EHR Incentive Program.

According to a DOJ press release, “the United States alleged that Coffey Health System falsely attested that it conducted and/or reviewed security risk analyses in accordance with requirements under a federal incentive program for the reporting periods of 2012 and 2013. The government contended that the hospital submitted false claims to the Medicare and Medicaid Programs pursuant the Electronic Health Records (EHR) Incentive Program.”

“Medicare and Medicaid beneficiaries expect that providers ensure the accuracy and security of their electronic health records,” said Stephen McAllister (above), United States Attorney for the District of Kansas, in the DOJ press release. “This office remains committed to protecting the federal health programs and to hold accountable those whose conduct results in improper payments.” (Photo copyright: US Department of Justice.)

How Providers Receive EHR Incentive Program Funds

The original EHR Adoption Incentive Program was part of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The federal government enacted the program as part of the American Recovery and Reinvestment Act of 2009 (the Recovery Act), which was an amendment to the Health Insurance Portability and Accountability Act (HIPAA). 

The Recovery Act allocated $25 billion to incentivize healthcare professionals and facilities to adopt and demonstrate meaningful use (MU) of electronic health records by January 1, 2014. The federal Centers for Medicare and Medicaid Services (CMS) released the incentive funds when providers attested to accomplishing specific goals set by the program.

The website of the Office of the National Coordinator for Health Information Technology (ONC), HealthIt.gov, defines “meaningful use” as the use of digital medical and health records to:

  • Improve quality, safety, efficiency, and reduce health disparities;
  • Engage patients and their families;
  • Improve care coordination and population and public health; and
  • Maintain privacy and security of patient health information.

The purpose of the HITECH Act was to address privacy and security concerns linked to electronic storage and transference of protected health information (PHI). HITECH encourages healthcare organizations to update their health records and record systems, and it offers financial incentives to institutions that are in compliance with the requirements of the program.

When eligible professionals or eligible hospitals attest to being in compliance with Medicare’s EHR incentive program requirements, they can file claims for federal funds, which are paid and audited by the Department of Health and Human Services (HHS) through Medicare and Medicaid.

Institutions receiving funds must demonstrate meaningful use of EHR records or risk potential penalties, including the delay or cancellation of future payments and full reimbursement of payments already received. In addition, false statements submitted in filed documents are subject to criminal laws and civil penalties at both the state and federal levels.

EHR Developers Under Scrutiny by DOJ

EHR vendors also have been investigated and ordered to make restitutions by the DOJ. 

In February, Greenway Health, a Tampa-based EHR developer, agree to pay $57.25 million to resolve allegations related to the False Claims Act. In this case, the government contended that Greenway obtained certification for its “Prime Suite” EHR even though the technology did not meet the requirements for meaningful use.

And EHR vendor eClinicalWorks paid the government $155 million to settle allegations under the False Claims Act. The government maintained that eClinicalWorks misrepresented the capabilities of their software and provided $392,000 in kickbacks to customers who promoted its product. 

Legal cases such as these demonstrate that the DOJ will pursue both vendors and healthcare organizations that misrepresent their products or falsely attest to interoperability under the terms laid out by Medicare’s EHR Incentive Program.

Clinical laboratory leaders and pathology groups should carefully study these cases. This knowledge may be helpful when they are asked to create and maintain interfaces to exchange patient data with client EHRs.

—JP Schlingman

Related Information:

DOJ Pursues More Electronic Health Records Cases

Electronic Health Records Vendor to Pay $57.25 Million to Settle False Claims Act Allegations  

Electronic Health Records Vendor to Pay $155 Million to Settle False Claims Act Allegations

Kansas Hospital Agrees to Pay $250,000 to Settle False Claims Act Allegations

EHR Sales Reached $31.5 Billion in 2018 Despite Concerns over Usability, Interoperability, and Ties to Medical Errors

Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data Should be Handled, Secured, and Kept Private

Direct-to-consumer (DTC) genetic testing has been much in the news of late and clinical laboratories, anatomic pathology groups, and biomedical researchers have a stake in how the controversy plays out.

While healthcare consumers seem enamored with the idea of investigating their genomic ancestry in growing numbers, the question of how the data is collected, secured, and distributed when and to whom, is under increased scrutiny by federal lawmakers, bioethicists, and research scientists.

However, should public demand for DTC testing find support in Congress, some lab companies offering direct-to-consumer genetic tests could find their primary source of revenue curtailed.

DTC Sales Skyrocket as FDA Authorizes Genetic Tests for Certain Chronic Diseases

Dark Daily reported last fall on one company that had its plans to distribute thousands of free genetic tests at a football game suspended due to privacy concerns. (See, “State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?” October 13, 2017.)

Nevertheless, consumer demand for DTC tests continues to rise. In a press release, Ancestry, a family genetic history and consumer genomics company, reported:

  • Record sales of AncestryDNA kits during the 2017 four-day Black Friday to Cyber Monday weekend, selling more than 1.5 million kits; and,
  • The 2017 sales were triple the amount of kits sold during the same period in 2016.

Possibly helping the sale of DTC genetic tests may be the US Food and Drug Administration (FDA) authorization last year of 23andMe’s Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions, including:

Senator Calls for Investigation of DTC Genetic Test Company Use of Patient Data

These are impressive sales. However, medical professionals may wonder how so much genetic data can be kept private by the testing companies. And medical laboratory leaders are not the only ones asking about privacy and the use of genetic test results.

In a November press conference, Senate Minority Leader Chuck Schumer called on the Federal Trade Commission (FTC) to look into genetic testing companies’ privacy and disclosure practices, noted NBC News.

“What those companies can do with all that data—your most sensitive and deepest info, your genetics—is not clear, and in some cases not fair and not right,” stated Schumer.

Congress took action in 2008 by passing the Genetic Information and Nondiscrimination Act (GINA), which bans employers and insurers from making decisions about people based on genetic predispositions to disease.

However, lawmakers also recently introduced House Bill 1313, the Preserving Employee Wellness Programs Act. It reads, in part, “… the collection of information about the manifested disease or disorder of a family member shall not be considered an unlawful acquisition of genetic information with respect to another family as part of a workplace wellness program offered by an employer ….”

“We’re injecting terrible opportunities for discrimination in the workplace,” Robert Green, MD, Professor of Medicine (Genetics) at Harvard Medical School, told Gizmodo.

Robert C. Green, MD, MPH

Robert C. Green, MD, MPH (above), Professor of Medicine, Harvard Medical School; Associate Physician, Brigham and Women’s Hospital; Geneticist, Brigham and Women’s Hospital; and Director, Genomes2People Research Program at Brigham and Women’s Hospital, believes weak genetic privacy laws are inhibiting research and clinical care. “People decline genetic tests because of concerns over privacy and genetic discrimination, especially insurance discrimination,” he told Gizmodo. “This is stymying biomedical research and people’s access to healthcare.” (Photo copyright: Harvard Medical School.)

HIPAA Enables Selling of Anonymized Patient Genetic Data

Peter Pitts, former FDA Associate Commissioner, and President and Co-founder of the Center for Medicine in the Public Interest, a non-profit medical issues research group, blames the release of data by DTC genetic test companies on the Health Insurance Portability and Accountability Act (HIPAA), a law he says makes way for “anonymized” sale of patient data.

“The Portability Act was passed when genetic testing was just a distant dream on the horizon of personalized medicine,” Pitts wrote in a Forbes commentary. “But today that loophole has proven to be a cash cow. 23andMe has sold access to its database to at least 13 outside pharmaceutical firms … AncestryDNA recently announced a lucrative data-sharing partnership with the biotech company Calico.”

For its part, in an online privacy statement, 23andMe noted, “We will use your genetic information or self-reported information and share it with third parties for scientific research purposes only if you sign the appropriate consent document.”

Similarly, Ancestry points out in its posted privacy statement, “We share your genetic information with research partners only when you provide us with your express consent to do so through our informed consent to research.

Consumers Speak Out on Privacy; States Study Laws and Genetic Testing by Research Hospitals

How do consumers feel about the privacy of their genetic test data?  According to a news release, a survey by 23andMe found the following:

  • 80% of Americans are concerned about DNA testing privacy; however,
  • 88% have no awareness or understanding of what testing companies do to protect information; and,
  • 74% of people are, nonetheless, interested in genetic testing.

Meanwhile, as states promulgate various genetic privacy laws, a paper published at SSRN by researchers at the Massachusetts Institute of Technology (MIT) and the University of Virginia (UV) examined how different state laws affect patients’ decisions about having genetic testing performed at various research hospitals.

The MIT/UV study focused on genetic testing by research hospitals as opposed to the DTC genetic testing by private companies. The paper explained that states have one of three types of laws to protect patients’ privacy in genetic testing:

  • “Require the provider to notify the individual about potential privacy risks;
  • “Restrict discriminatory use of genetic data by employers or insurance companies; and,
  • “Limit redisclosure without consent.”

Findings, netted from more than 81,000 respondents, suggest:

  • When genetic data are explained in state laws as patient property, more tests are performed;
  • Conversely, state laws that focus on risk, and ask patients to consent to risk, lead to less people giving the go-ahead for genetic testing.

“We found a positive effect [on the number of tests] was an approach where you gave patients the potential to actually control their own data,” Catherine Tucker, PhD,  Distinguished Professor of Management at MIT and one of the study researchers, told MIT News.

Whether the provider of genetic tests is a private testing company or a research hospital’s clinical laboratory, privacy continues to be a concern, not just to physicians but to federal lawmakers as well. Nevertheless, healthcare consumers and patients who receive comprehensible information about how their genetic data may be used seem to be agreeable to it. At least for now, that is.

—Donna Marie Pocius

Related Information:

AncestryDNA Breaks Holiday Sales Record Black Friday to Cyber Monday

Senator Calls for More Scrutiny of Home DNA Test Industry

The Present and Future Asymmetry of Consumer Genetic Testing

Are Our Terrible Genetic Privacy Laws Hurting Science?

The Privacy Delusions of Genetic Testing

National Survey Shows Strong Interest in DNA Testing

Privacy Protection, Personalized Medicine, and Genetic Testing

How Privacy Policies Affect Genetic Testing

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

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