Big Tech and Health: Implications for HIPAA?

This week, Apple announced that it will now allow users to download and view portions of their medical records on their Apple products. This function will become a part of Apple’s Health app, and now enables consumers to transfer clinical data from their health care providers to their iPhones. This tool will allow for “easier sharing across multiple providers,” meaning that users will be able to bring their medical records with them in the event of switching doctors or moving, rather than going through the process of getting their records faxed or sent by the office itself. However, the risk to consumers may be substantial. By having a considerable amount of protected health information (PHI) on a mobile device or wearable technology, it exposes the consumer to the potential risk of hacking and theft.

While this feature has just begun beta testing, with some high-profile medical institutions among the first to provide access to their patients, the introduction of this feature leaves open some important questions regarding the Health Insurance Portability and Accountability Act (HIPAA).

Although HIPAA does not act as a general medical privacy law, HIPAA standardizes the privacy of health information in the United States by creating baseline protections for health information. The privacy rule, promulgated by the Department of Health and Human Services, focuses on HIPAA in its relation to “covered entities” and “business associates.” In doing so, the rule created a loophole that seems to be growing steadily as more and more of the population engages with websites, phone applications, and wearable technology that collects and stores health information, known as “non-HIPAA” health data.

As most of this health data falls outside of the scope of HIPAA’s protection, there is a serious question as to if, and how, this data should be regulated and protected. While Apple stated that it will not be able to view users’ medical data, which is encrypted, accessible only with the users’ password, and stored locally on the iPhone, users are also given the option to share such data with the company.

While the Apple was initially reluctant to consider the potentiality for HIPAA privacy and security issues, the tech giant has signaled, by seeking and retaining “Privacy Counsel” focused on HIPAA and health, that they are taking the issue of health privacy and security seriously. Recently, CEO Tim Cook stated that “the holy grail of the watch is being able to monitor more and more of what’s going on in the body.” As the Apple Watch itself has been held out to be and adopted as a “health monitoring device,” with 80 percent of its consumers utilizing the health and fitness tracking function, it becomes even more important for Apple to consider adopting a HIPAA-compliant system to protect the plethora of data collected by such devices.

As a recent report issued by the Obama White House demonstrated, “big data analytics” wield the potential to undermine established civil rights protections in how personal information is used in housing, credit, employment, health, education, and the marketplace. With implications such as these, one has to wonder what the next steps will be in addressing the proliferation of non-HIPAA data.

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Affects of Sexual Abuse by Physicians

As children we are all told to trust our doctors; they are the people who cure our ailments and keep us healthy. Therefore, we trust our doctors with our most private and intimate problems. A shared story among the Larry Nassar sexual abuse survivors is that they placed their trust in him as their doctor to heal them, and he violated that trust. Larry Nassar, the former USA Gymnastics doctor, was sentenced to 40 to 175 years in prison after he pled guilty to ten counts of sexual assault. Over 150 women gave impact statements at his sentencing hearing, and nearly all of them asked for a sentence that would set a precedent that manipulation of trust and sexual abuse by a doctor will not be tolerated.

Medical Obligations and Malpractice

“[You] used up every ounce of innocence not only abusing me but the oath you took when becoming a doctor to respect the privacy of your patients and not play God”

One survivor noted in her testimony that Nassar took an oath as a doctor to respect the privacy of his patients and he had violated the trust of all of his patients and their families when he committed sexual assault. Another survivor began her testimony began by stating that Nassar breached his duty of care to her and did not follow the medical regulations he was under.

Although the standards for medical care vary by state, in general, doctors have a duty of care to their patients. Medical malpractice is defined as a violation of the standard of care from that injures the patient. The American Medical Association’s “Principles of Medical Ethics” lay out the ethical obligations of physicians; these include, but are not limited to, respecting human dignity, patients’ rights, and standards of professional conduct. All doctors swear the Hippocratic oath before they become begin to practice medicine; the oath calls for doctors to protect the privacy of his patients, to do no harm, and to not play God.

Sexual abuse breaches a doctor’s duty to his patient, legally, ethically, and morally. If you want to see how your state manages doctor sexual abuse cases please see http://doctors.ajc.com/states/

Consequences of Sexual Abuse for Doctors

Talk is worthless to me… we need to demand real change and we need to be willing to be able to fight for it. It is clear now that if we leave this up to these organizations, history is likely to repeat itself”

While doctors are subject to the law, their oath, and medical board regulations, to not have sexual relations with a patient a study done by the Atlanta Journal –Constitution found that of the nation’s 2,400 doctors that were publicly disciplined for sexual misconduct with a patient, half still have their medical license today. Even more, when a medical board is composed chiefly of physicians, a doctor accused of sexual abuse is more likely to be allowed to continue practicing. Sexual abuse by doctors is often brushed off as rare; however, as Nassar’s case has shown us, rare does not mean unimportant, rare does not mean infrequent, and rare does not mean unpunishable.

Allegations of sexual abuse against Nassar began in the 1990s; however, the Michigan state disciplinary board did not revoke Nassar’s medical license until April of 2017, nearly nine months after The Indianapolis Star published an investigation of USA Gymnastics’ handling of sexual abuse and a formal complaint against Nassar had been filed with the MSU police; not to mention nearly twenty three years after dozens of sexual abuse allegations.

Effects of Sexual Abuse for Survivors

For me, it was a girl getting out her gun and laying it on the bed just to remind herself that she has control over her own life”

Sexual assault is undeniable married to mental health impacts. Among survivors of sexual abuse, anxiety, depression, and PTSD are common diagnoses. The women who testified several discussed the lasting mental health issues they now suffer from as a result of the abuse. Anxiety, depression, and eating disorders are only the tip of the iceberg of conditions that the survivors mentioned in their testimony. Several of the survivors mentioned that they currently seek counseling to cope with the effects of their abuse, others detailed suicidal thoughts, and one mother discussed how Nassar’s abuse contributed to her daughter’s depression and eventual suicide in 2009.

Nassar is the most recent and the most infamous example of a doctor abusing his privilege to treat patients with abuse and how our system can perpetuate the cycle of malpractice and abuse.

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New Year’s Resolution: Drug Abuse Prevention

The start of a New Year is often a time to reflect on the past and make resolutions to improve in the future. An ever going epidemic in the United States is drug abuse. Drug overdoses are currently the leading cause of death among Americans under the age of fifty. Research in 2017 has indicated that trends in drug abuse and overdose death rates are at an all-time high. With more than 64,000 drug overdose deaths estimated in 2016, the sharpest increase occurred among deaths related to synthetic opioids with over 20,000 overdose deaths.

Although there are delays in toxicology reports and inconsistencies in reported data, it is nevertheless clear that drug abuse and overdose are problems of exceptional and imminent importance.

The question, now, is what does this mean for 2018? Goals moving forward involve prevention, rehabilitation, and education for people across the county. These encompass both health and legal objectives, as they are very much intertwined, and addressing the drug epidemic will keep people safer, healthier, and also out of the criminal justice system.

Health objectives include medical advancements as well as treatment. There have been many medical advances in the war against opioid overdose, including the FDA approval of Naloxone, designed to rapidly reverse opioid overdose. While paramedics and specially trained responders typically administer Naloxone via injection, there are also nasal sprays and other forms of medicine that are more accessible to the general population. While the problem of drug abuse needs to be tackled starting with prevention, advances such as these are extremely important for rehabilitation purposes for people that struggle with substance abuse and addiction. It also can immediately save lives in grave situations.

Along with scientific medical advancements like Naloxone, research has shown that drug abuse treatment can help people with the many aspects and consequences of drug abuse. Drug abuse is very much tied to both legal and health problems. Treatment targeted towards individuals in the criminal justice system can help alter their outlooks and actions toward drug use, avoid relapse, and positively disconnect themselves from a life of substance use and crime. Treatment can be effective, whether voluntary or ordered by the court.

There are many places and organizations dedicated to drug abuse rehabilitation and prevention. Programs like Narconon International are devoted to education to prevent drug abuse and addiction, specifically targeting youth. They point to the fact that in today’s society, we are inundated with media and celebrities and influences constantly. Educating youths who are vulnerable to these messages and influences is vital to prevention. Reaching out to young people can help to combat the perpetual abuse cycles that we see in both the health world and the criminal justice world.

The 2018 National Rx Drug Abuse and Heroin Summit will take place this year in Atlanta, Georgia in April. The National Rx Drug Abuse and Heroin Summit is a congregation of experts from local, state, and federal agencies, businesses, academia, treatment providers, and allied communities impacted by prescription drug abuse and heroin use. This annual gathering offers an opportunity to discover what is effective in deterrence and healing.

It is very clear that drug abuse prevention is a top priority for our country as we ring in this New Year. For more resources and information about drugs, drug abuse, and prevention, please visit and share the 2017 version of the DEA Resource Guide, Easy-to-Read DrugFacts, and The Science of Drug Use – Discussion Points.

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Pharma-Funded Charities v. Health and Human Services

The battle to control high drug prices between pharmaceutical companies, insurance companies, and the government continues to rage on. On January 8, Patient Services Inc. (PSI), a patient-assistance charity, launched the newest crusade by suing the Department of Health and Human Services (HHS).

What is a patient-assistance charity?

A patient-assistance charity works to help patients with expensive prescriptions pay for their medication. Though seemingly benign, patient-assistance charities get most, if not all, of their funding from pharmaceutical companies. These are the same pharmaceutical companies that have, since the heyday of Martin Shrekli, been criticized countless times by the media and dragged into Congress for raising drug prices.

This is where a patient-assistance charity comes in and provides a shield for badly bruised companies. Charities help quell public criticism for increased drug prices because companies, by pointing to the charities, are able to ensure critics that patients who need their drugs will be able to afford them. Shrekli even did this for Daraprim, the drug that he raised the price by 5,000%. Within days of raising the price, Turing, the company that manufactures Daraprim, called PSI and created a fund for patients with toxoplasmosis, the infection that is most often treated with Daraprim.

The good publicity is only icing on the cake. The real reason pharmaceutical companies donate to patient-assistance charities is because it is profitable. For every $1 million spent on a charitable donation, the company has the potential to generate $21 million in revenue. The company also receives a tax deduction for their donation. Companies profit because they only have to pay a couple hundred dollars to cover the patient’s co-pay and they will receive thousands of dollars for the remaining cost of the drug from the patient’s insurance company.

The funds also allow drug companies to get around anti-kickback provisions. Pharmaceutical companies cannot give patients enrolled in Medicare or Medicaid a co-pay coupon (coupons that help reduce or eliminate co-pay costs for a certain drug). However, companies are authorized to give to patient-assistance charities that help patients on Medicare or Medicaid.

There are rules governing the relationship between the companies and charities. Companies are not allowed to dictate how the donations are spent, but this doesn’t always play out in practice. An IRS analysis of the Chronic Disease Fund (CDF) found that almost all of the financial assistance went to patients taking drugs from their biggest funder, Genentech. In 2011, Celegene gave CDF $48.8 million to support a fund for multiple myeloma patients and 98% of the money from that fund went to patients taking drugs from Celegene.

Patient Services Inc v. Health and Human Services

In its suit, Patient Service Inc v. Health and Human Services, PSI alleges that the federal oversight of its charity violated its free speech rights by limiting its ability to communicate with donors. PSI says the oversight is burdensome and threatens the existence of the organization.

PSI might be going on the offensive in reaction to the Office of Inspector General (OIG) of HHS revoking its favorable advisory opinion of another patient-assistance charity, Caring Voice Coalition (CVC). OIG rescinded its favorable opinion because CVC gave drugmakers data that could help them see if their contribution was being directed for their own drugs, potentially giving the companies “greater ability to raise the prices of their drugs while insulating patients from the immediate out-of-pocket effects.” The coalition has since announced that it will no longer be able to offer any financial assistance in 2018. On top of this, patient-assistance charities are also feeling the heat from the U.S. Attorney’s Office in Massachusetts and the Internal Revenue Service.

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Clarity in the Emerging Biosimilars Market

Blockbuster biologics have represented the forefront of the biopharmaceutical industry for nearly two decades. Biologics are drug products that are derived from natural sources and include a wide range of products such as vaccines, allergenics, gene therapies, and recombinant therapeutic proteins. Biologics offer treatments for diseases that conventional drugs have been unable to sufficiently treat or have previously been considered untreatable altogether. Indeed, biologics, which are coined “blockbusters” upon generating over $1 billion in annual sales, have dominated U.S. markets recently. For example, Humira, a biologic drug, has been considered the top-selling drug since 2013. Despite the widespread success of biologics among manufacturers, this progress has not yet translated to the pockets of patients. Instead, biosimilars, which are therapeutic drugs that are similar but not structurally identical to an approved brand-name biologic, tout expected savings of $54 billion from 2017 to 2026. The emerging biosimilars market promises significant cost reductions and increased clarity regarding the approval of new biosimilars.

Enacted as part of the Patient Protection and Affordable Care Act (ACA) in 2010, Congress developed a new regulatory approval pathway for biosimilars through the Biologics Price Competition and Innovation Act (BPCIA). Specifically, the BPCIA created an abbreviated licensure pathway for biosimilars that are highly similar to already approved “reference” biologics in terms of safety, purity, and potency. The BPCIA also set forth FDA-administered periods of regulatory exclusivity for certain brand-name biologics and biosimilar products, as well as procedures to resolve patent disputes. The primary goals of the BPCIA include increasing access to lifesaving medications, providing more treatment options, and lowering health care costs through increased competition. As well, comparable to how generic drugs avoid duplicating costly clinical trials to attain approval, biosimilars also avoid these costs.

By way of background, and to better understand the events leading up to creating a biosimilar pathway, generic drugs merit discussion. In 1984, the Hatch-Waxman Act was enacted by creating an abbreviated regulatory pathway for generic chemical drugs. The generic drug industry subsequently exploded and the changes in regulation have allowed generics to capture significant market share from brand-name drug manufacturers. The generics market share has increased from merely 19% of dispensed drugs in 1984 to nearly 89% in 2015. The Hatch-Waxman Act allows generic drugs to piggyback off of the efficacy and safety data of a brand-name drug. Central to the Hatch-Waxman Act are the competing interests of medical innovation and access to medicine. Accordingly, the U.S. patent system plays a significant role in the pharmaceutical industry. During the time of congressional debate and subsequent implementation of the Hatch-Waxman Act, the biotechnology industry was still in its infancy, and biologic drugs were specifically not included under the pathway.

There are several key differences between the drugs regulated under the BPCIA as compared to the Hatch-Waxman Act. Biologic and biosimilar drugs are more complex than chemical drugs. Biosimilar drugs are often compared to generics and even called “generic biologics,” but this label is improper. Strictly speaking, a pharmacist can swap a generic drug for a brand-name drug, but biosimilar drugs cannot be swapped. However, many states have laws addressing pharmacy-level substitution, which is a practice that permits a pharmacist to substitute one drug product for another without consulting the prescriber. Another distinguishable aspect between the BPCIA and the Hatch-Waxman Act is how patent rights are enforced. Unlike the Hatch-Waxman Act, the BPCIA does not tightly link FDA approval with patent rights. Nonetheless, patent disputes have been the subject of every lawsuit concerning the BPCIA to date. Currently, there are nine approved biosimilars in the United States, but only three have launched on the market. Patent litigation envelops the approval process for biosimilars and although uncertainty remains in the biotechnology industry, the biosimilar approval pathway has gained clarity.

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