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Researchers at a national laboratory discovered a weakness in one commonly used open source software for genomic analyses, according to a new report.

Sandia National Laboratories experts notified the developers of their discovery, and the vulnerability has been patched in the latest release of the software.

™ that genomics work can be beset by cybersecurity issues — and the burden to bolster safeguards is on healthcare systems.

 “The process of using genomic information to customize treatment requires genome sequencing and comparison to a standardized human genome sequence,” said Ravi Iyer, Ph.D., of the University of Illinois at Urbana-Champaign. “This process often requires the data to sometimes travel over insecure channels which presents problems from a security point of view.  In order to fully embrace genomic medicine we must ensure the security and privacy of all genomic data.”

Iyer and other Illinois researchers simulated the process of genomic mapping using a Sandia platform, looking for weaknesses. Both teams continue to test other industry software for lapses in security.

One program commonly used in personalized medicine is the Burrows-Wheeler Aligner, or BWA. The first step in using the tool is sequencing their entire genome, followed by comparing that sequence to the standardized human genome. The end goal is to guide the most ideal medical treatment.

When BWA pulled in standardized genomic data from various government servers, the data traveled across insecure channels, the investigators learned. This left open an opportunity for a cyberattack, in which a hacker could intercept the data. A number of possibilities open from there, including a nightmare scenario posited by the researchers: malware altering a patient’s data, resulting in incorrect prescription drugs.

When they discovered the problem, the team alerted the developers as well as public agencies such as the U.S. Computer Emergency Readiness Team in order to more widely disseminate information about the issue.

Iyer said that cybersecurity and privacy problems for genomic data in particular differs from concerns in the sphere of finance, the electrical grid, or infrastructure.

“In particular genomic data are unchanged over an individual’s lifetime, meaning that unlike the loss of personal financial data or passwords loss of genomic data is unrecoverable,” he said. “The technologies that have made these advances in genomic medicine require high performance computing, large amounts of data storage and complex and complicated computational pipelines. The safety, security and privacy protections in these systems warrants vigilant and continuous monitoring and additional studies to determine best practices."

Corey Hudson, Ph.D., a bioinformatics researcher at Sandia, recommended several “cyberhygiene” tips:

Use software that protects sequencing data from alterations

And unlike the electrical grid or infrastructure, where it is common practice to analyze open source software for vulnerabilities, genomics security has so far left that potential untapped.

“Our goal is to make systems safer for people who use them by helping to develop best practices,” Hudson said.

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The software has since been patched, but the weakness could have left individuals’ genomic data vulnerable.

Genomics Data Pipeline Could be Open to Hacking, Lab Finds

Both distributed-ledger technologies (DLT) and the Internet of Things (IoT) would contribute greatly to health-related data sharing, according to 

Investigators from Spain, Denmark and Norway successfully demonstrated how health-related data could be collected and published to an online network with different encryption and privacy options. This system could be the model upon which to build when creating secure and efficient health data sharing marketplaces without fees to handle the amount of data generated by IoT devices.

“To overcome these barriers that hinder the full use of valuable health data,” the study authors wrote, mentioning expenses and security as two obstacles, “it is necessary to develop advanced systems to accelerate secure, fee-less, tamper-resist and high-scalable health data sharing.”

Researchers aimed to develop a health-related data sharing system that would integrate IoT and DLT. They also hoped to build a prototype to test the feasibility of their creation. IoT data came from both wearable devices (such as smartphones, smartwatches and more) and stationary air quality sensors (to collect data about temperature, humidity, air quality and noise), the investigators said.

In the study, participating patients could publish their health data and a doctor could publish their evaluation result to a networked called the Tangle. Patients subscribed to doctors’ channels to receive the result. However, wearable smart devices could not publish or receive data directly to and from the Tangle. Investigators designed the prototype so that a gateway layer would be necessary.

Subscribers could access the Tangle data when published to the public mode. But they needed an additional decryption key to access data published to the restricted mode. Environmental data were published publicly, while patient report data and tremor evaluations were published in the restricted mode.

Three types of data were tested: tremor level, based on smart watch acceleration; patient reports from a smartphone; and environmental data from air sensors.

Quicker, More Secure Health Data Exchange

In 100 trials, investigators found no obvious differences in waiting time to publish to Tangle, despite differences in each data type’s message length and encryption level (public or restricted). The time varied from a few seconds to more than one minute, in some cases.

“Currently, the bottleneck of the data publishing speed is the total number of nodes connected to the Tangle network and the condition of the specific node used by the publishing device,” the study authors wrote. “It is expected that the time to publish data from a local server or from the single board computer should be similar.”

While there is still room for improvement, the investigators continued, they hypothesize that the more nodes there are to connect to the Tangle network, the faster a transaction can be approved.

The Implications of Better Health Data Sharing

“Our research work has shown it is possible to develop a secure health-related data sharing system by converging the emerging DLT and IoT technologies,” study author Raghava Rao Mukkamala, Ph.D., of the Copenhagen Business School, told 

™. “It makes possible a reliable marketplace for the individuals to share their health-related data with hospitals, researchers, industry companies or any other organizations in a secure and controllable way. In return, individuals can benefit from their own data in monetary, medical services or other forms.

“On the other hand, researchers and companies will be able to gather relevant data for their studies, clinical trials or product development,” Mukkamala continued. “Therefore, there will be plenty of opportunities for secure health-related data sharing using emerging technologies like DLT and blockchain technologies, which can lead to lead optimized healthcare processes with enhanced efficiencies.”

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Researchers from the UT Southwestern Medical Center outlined their suggestions that evidence based medicine — the approach that embraces individualized care – in a review published in the journal 

. The researchers called over treatment “pervasive” and said it “leads to potential patient harms and excessive costs in health care.” Overuse, they added, can account for as much as a fifth of the estimated $750 billion of wasted spending in the health care industry in the United States.

By applying evidence-based medicine approaches to individualized treatments, physicians can prevent over treatment and promote patient centered care, the researchers explained. They applied their reasoning to a discussion about the treatment of type 2 diabetes.

The investigators first examined the use of absolute rather than relative estimates of benefits to inform treatment decisions. They said that in diabetes cases, published studies indicate that after 10 years of intensive glycemic control, a patient may only experience mild positive effects. Additionally, risk for cardiovascular disease typically drops. To estimate the absolute benefit, the researchers were forced to rely on simulations rather than clinical outcomes.  In these scenarios, it became clear that the potential benefit of intensive glycemic control declined significantly with the age at which the patient was diagnosed.

“Relying on relative risks can vastly over estimate the benefits from treatment, which is why absolute risks are the preferred method to inform therapeutic decisions,” the study authors wrote.

The next part of the study discussed the time horizon to benefit of treatments, where the researchers determined that the patient’s life expectancy is a significant factor. For example, 

, a diabetes patient’s life may be shortened by up to nine years because of their diagnosis. Additionally, the researchers reported, the first time a patient is hospitalized for heart failure, their five-year mortality rate reaches 70 percent. The researchers said that because of these such mortality rates, intense glycemic control for diabetes may not have any benefit beyond a conventional glycemic control strategy.

The study authors also considered the evidence based medicine principle of balancing potential harms and benefits. Risks, which can also be individualized, usually include weight gain, severe hypoglycemia and a decrease in quality of life on an intensive glycemic control regimen. The researchers conceded that while patients may experience net benefits from intensive glycemic control, those with greater risk for microvascular and cardiovascular disease compared to those of average risk, may find additional benefit in a more intense regimen. But, they said, individuals with lower than average risks have even less potential to see benefits from an intensive glycemic control program.

Shared decision-making, the fourth and final pillar of evidence based medicine, revealed to the researchers the importance of the patients’ values and preferences that go into treatment decisions. Physicians should follow these four steps, they said: 1) explain to the patients that there exists an understood method on how best to treat the disease; 2) present alternative choices on the basis of the best available medicine; 3) support conversation between the therapeutic choices and best methods of implementation based on values and lifestyle, including social support, financial means, and workload factors; and, 4) come to a joint decision.

“Evidence based medicine is often misunderstood as a call for universal, cookie-cutter medicine, which has led to an epidemic of overtreatment in type 2 diabetes,” senior author Dr. Oanh Nguyen, explained in a press release. “Instead, evidence based medicine is a critical tool in the physician’s arsenal to provide individualized and person centered care.”

Currently, the study authors added in the statement, the standard of care for type 2 diabetes includes strict blood sugar control. But because that may only provide a modest benefit, they said, it can decrease quality of life in patients and even lead to possible harm stemming from the therapy.

An Evidence-Based Medicine Approach to Antihyperglycemic Therapy in Diabetes Mellitus to Overcome Overtreatment

The study authors were quoted in a UT Southwestern news release entitled “

Researchers urge use of evidence-based medicine to avoid overtreatment of type 2 diabetes

The investigators called over treatment “pervasive” and said it “leads to potential patient harms and excessive costs in health care.”

Rachel Lutz

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