Category Archives: Uncategorized

Electronic Health Records: The Dark Side of Digitizing Health Data in the Online Era

The Electronic Health Record (EHR) is permeating the healthcare industry. Easily accessible “minute clinics” and mobile apps providing diagnostic services are all fortuitous results of the increasing digitization of our medical history. While there are many clear benefits to having an EHR—providing accurate and better healthcare, better clinical decision making, and lower healthcare costs—there are numerous privacy risks associated with EHR utilization.

The EHR was a little-known concept when President George W. Bush broached the idea of computerizing health records in his 2004 State of the Union Address. Since then, the healthcare industry has seen a national push to become 100% EHR-dependent; a mission bolstered by President Obama promoting the use of EHRs in both the American Recovery and Reinvestment Act as part of the Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009 and the Affordable Care Act (ACA) of 2010.

Private industries and the general public are increasingly buying into the idea of EHRs as well; according to the Agency for Healthcare Research and Quality, there has been an upward trend in the percentage of patients who find the implementation of EHRs important. There has also been a year-over-year increase in the percentage of healthcare providers who have adopted EHRs, reaching 67% in 2017.

However, this progress toward 100% EHR utilization has also caused increased privacy concerns as EHRs contain a patient’s most sensitive data. These medical records are valuable on the black market as they include a wide range of personal information such as medical history, social security numbers, and insurance details. The permanency of this information provides criminals enough data to completely steal an individual’s identity as well as the ability to commit a wide array of other crimes.

In the summer of 2016, a rogue online actor known as “thedarkoverlord,” stole 655,000 health records from three healthcare providers in the United States. The hacker quickly put the stolen records up for sale on the dark web for an asking price of $700,000. The anonymous hacker told Vice’s Motherboard publication that “[t]he data could be used for anything from getting lines of credit to opening bank accounts to carrying out loan fraud and much more.” This data breach represented a mere 2.4% of all stolen electronic health records in 2016.

More often than not, the burden to resolve the theft of medical records—such as in the case of “thedarkoverlord”—rests with the patient. According to Ponenom Institute’s Fifth Annual Study on Medical Identity Theft, “[s]ixty-five percent of medical identity theft victims […] had to pay an average of $13,500 to resolve the crime.” The heavy financial burden and continued attacks directly affect the public’s concern for its privacy. In 2015, 68% of patients were not confident that their healthcare providers could protect their medical records from loss or theft.

To prevent and combat security concerns, lawmakers have enacted regulations “to protect the privacy of individuals’ health information while allowing covered entities to adopt new technologies to improve the quality and efficiency of patient care.” These competing interests have become more difficult to balance with the increasing reliance on EHRs and thus the increasing opportunity to steal data.

The Health Insurance Portability and Accountability Act (HIPAA) has been the cornerstone legislation on health-data privacy and holds organizations responsible for breaches of data it protects, yet major data breaches still occur through company oversight. In an attempt to incentivize private entities to keep cybersecurity frameworks up to date, Ohio recently passed a law that creates a safe harbor against tort claims for companies who are victims of a data breach. In order to take advantage of this law, companies must comply with the strict state-mandated security framework criteria. Ohio’s innovative approach to cybersecurity enforcement aims to encourage all businesses to implement cybersecurity programs tailored to protect sensitive information while still allowing for technologies to improve.

When President Bush called for implementing EHRs in 2004, he—nor anyone—could have predicted the scale of the current data breaches. A healthcare system reliant upon EHRs is new territory for the health industry and will continue to draw in those who wish to steal its data. However, with continued reliance upon the protections of our regulations such as HIPPA and innovative methods to incentivize a high level of cybersecurity in the private sector, we can feel secure in our progress towards the future that EHRs can provide.

Leave a Comment

Filed under Uncategorized

The Prison System and Mental Health

In the United States, people with severe mental illness are three times more likely to be in a prison instead of a mental health institution. Forty percent of people with severe mental illness will also spend time in a jail, prison, or correctional facility. There are many people with mental health issues who are being punished, including being executed and kept in solitary confinement.


Even though people with intellectual disabilities may not be executed under the Eighth Amendment, the Supreme Court has held that people who are mentally ill may still be executed, including people will severe mental illnesses, and only that the insane may not be executed. The “insane” is defined as “those who are unaware of the punishment they are about to suffer and why they are to suffer it.” But the Court has also said that the Eighth Amendment requires prison officials to provide a system of ready access to adequate medical care, including mental health care. However, states have not always followed the Court’s guidance, particularly when it comes to solitary confinement and the death penalty. Between 2010 and 2017, twenty-six percent of prisoners who were executed had a history of mental illness or were treated with psychotropic medication. Currently, between five and ten percent of death row prisoners are estimated to be suffering from a mental illness.


In October 2018, Yale Law School issued a report that over 4,000 prisoners in solitary confinement have a mental illness. Solitary confinement can often exacerbate or even trigger a prisoner’s mental health issues. Prisoners are kept in total isolation for twenty-two hours per day for at least fifteen consecutive days. In New Mexico, for example, sixty-four percent of prisoners with mental health issues were kept in solitary confinement. Unfortunately, prisoners who are kept in solitary confinement often leave more mentally damaged than when they entered, and are less likely to successfully reenter society.


The prison system must change to help prisoners who have a history of mental illness, and not further criminalize them. Many states are considering legislation to end the practice of executing prisoners with a mental illness and there are other states that are ending or restricting solitary confinement. For instance, in the fall of 2017, Colorado established a procedure to immediately provide prisoners with treatment rather than place them in segregated lock-up.


Prisoners can also have difficulty obtaining treatment because their insurance may no longer cover their medications and they also do not have reliable access to therapy while in prison. Mental Health America made suggestions to improve mental health access for the incarcerated, including investing in mental health courts and creating systems of support for people who are incarcerated or recently released and who need access to a community-based service. States can also reevaluate Medicaid exclusions on prisoners, so prisoners can still obtain their medications and their mental health issues will not be exacerbated while incarcerated. Authors of an article in the American Journal of Public Health have additionally suggested providing telemedicine, integrated family counseling, and cognitive-behavioral therapies to complement medication and also reduce levels of reoffending. There also need to be better transitional plans for prisoners to reintegrate into the community and still obtain mental health treatment. Prisoners who received a professional diagnosis of a mental health disorder were seventy percent more likely to return to prison when they did not have any correctional intervention and treatment.


It may also be prudent to determine whether a new mental health standard should be established for prisoners who develop mental health issues while in prison. The Supreme Court will soon decide a case about the execution of a man who developed severe mental health issues will in prison, in which case there may be an answer soon.

Leave a Comment

Filed under Uncategorized

History Repeating Itself: The FDA’s Response to a Dangerous New Trend

For at least the last decade (as long as I can remember growing up), the health risks of tobacco and smoking cigarettes were obvious.  The movement to raise awareness about the dangers of smoking was well underway, as television commercials, printed advertisements, and teachers were educating young people about nicotine’s addictive qualities and the link between smoking and certain cancers.  Growing up in the 1990s–2000s, there was no doubt in our minds smoking was bad.

As times progress, obviously so does technology.  Every day it seems like technology endlessly advances as new and better gadgets hit the shelves. Better phones, better cameras, everything.  Now, however, the tobacco industry has intersected with the tech industry as the popular e-cigarette, or Juul, has gone viral. You likely see people smoking these thumb-drive looking gadgets on a daily basis.  Juul, as a company and brand, does not hide that their products contain nicotine and that nicotine is an addictive substance.  They market themselves as the first viable alternative for adult smokers. Their website even warns “smoking is bad for your health, and those who don’t currently use nicotine products should not start.” Even with this effort to promote safety and health, the e-cigarette craze has brought with it a great deal of health problems and arguably caused new risks rather than merely creating an alternative to old ones.  Why is it that young people, who have always known the dangers of cigarettes, start using the Juul?  Is it Juul’s marketing and targeting techniques?  Is it our inherent need in 2018 to have the newest, coolest technology?  This, of course, is hard to say.  But the problems are real, and the FDA has now stepped in and has particularly focused on Juul’s risks towards young people.

So, what is a Juul and how is it different from a cigarette? The Juul is a compact, USB-shaped vaping device. It is similar to other e-cigarettes, says cardiologist Holly Middlekauff, M.D., professor of medicine and physiology at the David Geffen School of Medicine at UCLA.  “The liquid is pretty much the same. It has solvents, nicotine, and flavorings,” Middlekauff told The solvents help deliver the nicotine and flavors in the form of tiny particles into the lungs. Unlike other e-cigarettes, the Juul is compact and rechargeable; and additionally has an internal temperature-regulating mechanism that prevents it from overheating or even exploding. The Juul has become particularly popular on social media, especially among young people. But as trendy as it is, the device still contains nicotine and is a major health concern, say medical experts.

In April 2018, FDA Commissioner Scott Gottlieb announced that he was forming a Youth Tobacco Prevention Plan aimed at stopping youth tobacco usage.  The FDA led a surprise inspection of the headquarters of Juul Labs in late September, retrieving more than a thousand documents it said were related to the company’s sales and marketing practices.  The FDA said it was particularly interested in whether Juul deliberately targeted minors as consumers.  “The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens,” the FDA said in a statement. “It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.”  The agency has given Juul and four other e-cigarette manufacturers a 60-day deadline to produce plans showing how they will limit access to teenagers.  It will certainly be interesting to see if this trend will go out of style soon, or if the FDA will need to take further steps to re-teach our youth the dangers of nicotine and cigarettes.

Leave a Comment

Filed under Uncategorized

The CVS-Aetna Merger: Potential Gain & Loss for Consumers in Light of Growing Consolidation

Earlier this month, the Justice Department approved a $69 billion merger between retail pharmacy company, CVS Health, and managed care company, Aetna. The approval of the merger was conditioned on an agreement that Aetna would sell its private Medicare drug plans. This merger was approved in the wake of a similar vertical integration of the pharmacy benefit management company, Express Scripts, by major insurance company, Cigna. Consolidation in the health care industry is a growing trend that will impact drug prices and the way in which millions of Americans receive health care. Expectedly, the CVS-Aetna deal has drawn high praise and consternation from a wide range of industry professionals.

CVS-Aetna merger supporters insist that consumers may enjoy lower prescription drug prices as a result of this consolidation. In a press release made shortly after the merger was approved, CVS Health President and CEO, Larry Merlo, said that “we’ll be able to offer better care and convenience at a lower cost for patients and payors.” Supporters allege that cutting out independent pharmacy benefit managers, the proverbial middlemen who negotiate drug prices with manufacturers and distributors, will cut costs and keep more money in patients’ pockets.

Additionally, proponents of this merger assured the Justice Department and consumers that this deal will increase access to health care and improve health outcomes for millions of Americans. Prospectively, CVS locations may offer a more comprehensive list of services previously reserved for individual and other institutional providers. In addition to prescription plans and flu shots, patients at CVS may soon be able to receive “care for everything from a sore throat to their diabetes,” which would have a significant impact on the nearly 95 million Americans that CVS Health provided prescription plans to last year. This prospect may be appealing to younger patients who, at least in other markets, value convenience, uniformity, and accessibility.

Notwithstanding the potential upsides of a formidable health care conglomeration, opponents of the CVS-Aetna merger are adamant that such consolidation means higher costs for consumers and limited options for care. One such opponent is the American Medical Association which described the merger as “anti-competitive,” and asserted insurers, not consumers, stand to benefit. Additionally, the CEO of National Community Pharmacists Association, Douglas Hoey, commented that “[f]or all of the talk about cost savings, prescription drug costs have clearly continued to rise despite previous vertical mergers like UnitedHealth’s 2015 acquisition of Catamaran…Moreover, the anticipated efficiencies CVS and Aetna tout may benefit the merged company more than the consumer, who is likelier to be driven to use health care resources chosen by the health plan rather than those of his or her own choosing.”

Skeptics also assert that parties to the merger are compelled not by patient health outcomes but rather by eventual competition and marginal benefits from streamlining operations. Critics are worried that the emerging trend of insurers having in-house pharmacy benefit managers, a possible feature of a CVS-Aetna conglomeration, will lead to profiteering and even less transparency in an industry plagued by special interest. While financial savings from the merger are likely, many worry that there is no apparent promise or enforcement mechanism which would ensure such savings are passed along to consumers.

The effects of the vertical merger between CVS Health and Aetna remain to be seen. In the coming years, patients may bear witness to a seismic shift in the health care landscape which begets greater access to care and lower costs for prescription drugs and treatments. It may be just as likely that consumers experience little to no change on these two fronts while increasingly dominant super-corporations stifle competition and sequester the would-be consumer savings. What is certain, however, is that mergers like this will increase in the immediate future as companies like Amazon and Wal-Mart continue to indicate competitive interest in the health care market. How the Justice Department, lawmakers, and consumers react could determine the future of health outcomes.

Leave a Comment

Filed under Uncategorized

The Bleeding Edge and the Unsettling Truth About Medical Devices Today

After its premiere on Netflix, the documentary, The Bleeding Edge,immediately received attention for its critical look inside the billion-dollar medical device industry in the United States. In the documentary, men and women across the country openly discussed how their lives were affected after they used FDA approved medical devices. Most of the critics in the film focused on Bayer’s Essure sterilization device and Johnson & Johnson’s vaginal mesh, while also shedding light on artificial metal hip replacements and Intuitive’s Surgical da Vinci robotic arm. The documentary’s investigation into the FDA’s regulatory process of medical devices shows that more often than not medical devices get on the market without proper testing.

The FDA conducts its regulation pursuant to the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act, which established three regulatory classes for medical devices. Several of the devices the documentary discussed are Class III devices, which “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Class III devices are subject to a pre-market approval process where companies must produce research that proves that the new device is safe and effective. Bayer’s Essure, Johnson & Johnson’s vaginal mesh, and artificial metal hips are considered implants, under the Class III definition, but most of these were not subject to this process.

Bayer’s and Johnson & Johnson’s devices made their way through the 510(k) certification, which was created for Class II devices that are less risky to patients. This certification process allows the FDA to certify a company’s new medical device based on evidence that it is “substantially equivalent” to another device already on the market. To be clear, this is not an approval process, instead, this is a clearance process that allows new medical devices to enter the market without requiring device testing.  This process is, in essence, a “loophole” and allows devices to hit the market at a faster rate. Most medical devices are now regulated under this loophole instead of the pre-market approval process.

A serious question still remains: Can we trust that devices are safe and effective when they are cleared but not approved through this certification process? The patients in The Bleeding Edgesay no, yet Bayer and many other companies say yes. Days after the documentary premiered on Netflix, Bayer hit the media calling the allegations in the documentary “inaccurate and [a] misleading picture of Essure” and described the documentary as an “anecdote” created to fit an agenda.

Patients continue to seek better regulation even if the medical device industry and the FDA seem to be unbothered by the film and defend their regulation. However, even before the film aired, Johnson & Johnson and Bayer faced several class action suits due to their products. Specifically, about 16,000 women have sued Bayer in a class action suit. This prompted the FDA to issue a warning to Bayer and ordered the company to conduct risk assessment studies, which in hindsight should have been required. Bayer will now take Essure off the market by the end of this year. This is good news for those affected by this device, but it is not the only one out there causing life-threatening problems.

The FDA has yet to try to bridge the gap in their current regulation of medical devices, but many supporters of the film hope it will encourage movement toward more thorough regulation and safety of medical devices. As technology and innovation continue to advance, regulating medical devices will only get worse unless the FDA closes the holes in its regulatory process and puts patient safety first.

Leave a Comment

Filed under Uncategorized