The push for IT advancements in health related fields in the wake of technological breaches

For over twenty-five years, health related industries have increased the use of technology hoping to make healthcare more accessible, affordable, and efficient. As early as the 1990s, medical providers have slowly migrated to electronic health records (EHRs) from traditional paper record keeping systems. With the adoption of legislation like the HITECH Act, HIPAA, and the Patient Protection and Affordable Care Act of 2010, the Federal government has supported the trend of advancing technological innovations in the realm of the health care.

With increased reliance on EHRs, the issue of patient privacy is more prevalent. Medical providers must ensure, more than ever, that electronic record keeping will not jeopardize patient privacy. Providers bear the same burden in regard to online platforms, which provide virtual medical services to consumers. Especially, in the wake of recent technological breaches, how can healthcare providers ensure that the steady trend of IT innovations in health related industries does not experience similar issues with security and breaches occurring as of late?

In a recent article in the healthcare section of InformationWeek, Alison Diana outlined several pros and cons of technological advances in healthcare over the past twenty-five years. Making the top of the ‘cons’ lists was privacy. Diana noted that although medical providers take numerous precautions and implement safety measures to prevent breaches, there are also factors that are more difficult to control that can lead to leaks. Diana specifically noted that human error and criminal activity are two factors that often contribute to privacy mishaps.

Do the benefits outweigh the downfalls?

The Office of the National Coordinator for Healthcare IT, an office within HHS, believes that healthcare IT has its benefits despite its shortcomings. Proper implementation of healthcare IT programs can lead to decreased healthcare costs, increased access to healthcare, provide various forums for patients to have access to personal medical records, and create a simplified efficient system for recording sharing amongst healthcare providers. However, some legislators feel that more can be done to ensure that privacy is in fact protected.

On September 18, 2014, Rep. Robert Hurt, R-Va. and Rep. John Barrow, D-Ga., introduced a bi-partisan bill in the House, proposing additional privacy rights for potential consumers of insurance plans pursuant to the ACA. The bill would allow individuals who do not opt-in to the Federal healthcare program to remove any personal information from the site that they provided in the application process. Currently that option is not available to potential consumers. After, a potential consumer provides his or her personal medical information on healthcare.gov, it cannot be removed even if that individual does not decide to purchase a plan. Rep. Hurt explained to Information Security Media Outlet that he was prompted to introduce the bill after a constituent expressed concern with his inability to remove his profile from Healthcare.org, which contained a myriad of personal information and health history, after deciding not to purchase healthcare from the site. Rep. Hurt explained that he had not received an explanation about the policy of keeping consumer information after contacting the Agency several times to inquire why the data was kept if insurance was not purchased. Rep. Hurt also attributes studies from the Government Accountability Office highlighting breaches to healthcare.gov as motivation to create the bill.

The bill will offer all consumers, potential and realized, increased security when using healthcare.gov, a concern that is prevalent with consumers. Having the ability to remove highly private, personal medical information from a government controlled website can help decrease the feeling that “big brother” is watching. As of yet, HHS has not taken any steps to address the concerns Rep. Hurt outlines in his bill. However, addressing the concerns raised in the bill could be beneficial for HHS to lure individuals in who may be on the fence about healthcare.gov.

 

 

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The United States Obesity Rate is Still Too High

The Robert Wood Johnson Foundation (RWJF) and the Trust for America’s Health (TFAH) released their September 2014 report on the current state of obesity in the United States. TheHill. As defined in the report, obesity is “an excessively high amount of body fat or adipose tissue in relation to lean body mass.” StateofObesity. Although obesity rates are plateauing, the rates remain high, leading to increased health problems for millions of Americans. StateofObesity. Adult obesity rates are now above 35 percent in two states, at or above 30 percent in 20 states, above 25 percent in 42 states, and above 20 percent in every state. StateofObesity. Rates of severe obesity apply to children as well, as more than one-in-ten children become obese between the ages of two and five. StateofObesity. This report projects that the United States’ general obesity rate will rise to 44 percent by 2030. NBC.

As recently as 1980, no state had obesity rates above 15 percent; in 1991, no state had obesity rates above 20 percent; in 2000, no state had obesity rates above 25 percent; and, in 2007, Mississippi was the only state above 30 percent. StateofObesity. As of 2011, more than 34.9 percent of adults were obese, and more than 68.5% of adults were overweight or obese as of 2011 to 2012. StateofObesity. Between 2011 and 2012, around 16.9 percent of children (ages two to nineteen) were obese, and 31.8 percent were overweight or obese. StateofObesity.

There are many preventable causes of obesity such as physical inactivity and limited or no access to healthy food. Eighty percent of adults in the United States do not meet the aerobic and muscle strengthening standards for physical activity. StateofObesity. In cases of child inactivity, all fifty states have adopted physical education standards that schools must follow; however, the scope of these requirements and the degree to which they are enforced and funded fluctuates. StateofObesity. Additionally, the types of foods available make it difficult to maintain a healthy weight. Besides general limited access to healthy foods, low-income families are unable to afford such products as they are generally higher priced than lower quality foods. Further, those who live in rural areas tend not to have access to a grocery store closer than ten miles away. StateofObesity.

Moreover, insurance coverage does not cover community health workers and obesity counselors. Medicare does not include medicine for obesity in its Part D drug benefit, nor does it give beneficiaries access to many lifestyle programs, which makes it even more difficult for those in need to attain the proper help in preventing serious health illnesses due to obesity. In turn, these chronic diseases are consuming a shocking amount of time and money throughout our healthcare system. StateofObesity.

It is highly important and beneficial to address these causes of obesity to prevent the serious health risks obesity poses. Overweightness and obesity have been shown to lead to the following health conditions: (1) type two diabetes; (2) heart disease; (3) hypertension; (4) risks before, during, and after childbirth; (5) cancer; (6) kidney disease; (7) arthritis; (8) dementia; (9) Alzheimer’s; and (10) mental health conditions. In the past twenty years, diabetes rates have almost doubled, and over eighty percent of diabetes patients are overweight or obese. Additionally, individuals who are overweight are more prone to developing high blood pressure, high blood fats levels, and high cholesterol, leading to heart disease and stroke. StateofObesity. According to the National Cancer Institute, around 84,000 cancer diagnoses per year are related to obesity. It has also been shown that extra fat affects how cancer treatments process. Wptv

What can America do to fix this? Our nation has been recently progressing by increasingly producing healthier foods. Coke, Pepsi, and Dr. Pepper proposed that they would aim to reduce the calories Americans obtain from beverages by twenty percent over the next ten years by marketing smaller sized drinks. WashingtonPost. The United States Department of Agriculture also updated the nutrition standards for school meals, snacks, and drinks for the first time in years. StateofObesity. In order to help the low-income community, food stamps have started including healthier foods as required by Obama’s enactment of the Farm Bill. StateofObesity.

To further combat obesity, agencies should implement policies where they can, for example, with child inactivity. Children are recommended to get sixty minutes of moderate to vigorous physical activity per day, which is not being considered in many school districts. Additionally, insurance plans should consider including obesity combatting treatment within their plans so that more individuals have a higher chance in solving this health issue.

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Call for Papers

Call For Papers

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The Drug-Resistant Threat: Incentivizing New Antibiotics

In 2012, Margaret Chan, Director-General of the World Health Organization (“WHO”), suggested that we are entering a “post-antibiotic era,” meaning that “[t]hings as common as strep throat or a child’s scratched knee could once again kill.” (Forbes)  The evolution of antibiotic resistant bacteria has led to the deaths of at least 23,000 annually in the U.S..  Terrifyingly, most of the infections causing these deaths, or deaths complicated by an antibiotic-resistant infection, occur within “healthcare settings such as hospitals and nursing homes.” (CDC – Threat Report)  Unfortunately, pharmaceutical companies have been loath to invest in antibiotics to combat the growing problem simply because it is not profitable, causing a steady decline in new antibiotic drug approvals. (CDC – US Threat)

The problem has not gone unnoticed by the Food and Drug Administration (“FDA”) or Congress.  For FDA’s part, the Agency, along with the Centers for Disease Control (“CDC”), has attempted to improve public awareness of the capabilities of current antibiotics, detailing when and how the drugs should be used. (CDC – Get Smart)  Furthermore, the Agency increased labeling requirements for antibiotics, instructing physicians when to prescribe antibiotics – “only to treat infections that are believed to be caused by bacteria” – and encouraging physicians to discuss proper use with their patients.  Finally, the FDA has created guidance documents for pharmaceutical companies “to evaluate how an antibacterial drug works for the treatment of different types of infections.” (FDA – Resistance)

On the legislative side, Congress passed the Generating Antibiotic Incentives Now Act (“GAIN”) in 2012.  The Act requires the FDA within two years of its enactment to create a list of “qualifying pathogens”, which will then be reviewed every five years.  “Qualifying pathogens” are those that the FDA has identified as posing a serious threat to public health.  The antibiotics that treat these qualified pathogens are known as “Qualified Infectious Disease Products” (“QIDP”).  GAIN also creates incentives for QIDP development.  The GAIN Act provides that any QIDP be eligible for fast track designation and receive priority review for marketing approval rather than proceeding through the standard and cumbersome New Drug Approval process.  Once the drug is approved, the Act grants the QIDP developer an additional five years of market exclusivity on top of that already guaranteed by the Hatch-Waxman Amendments, allowing the branded company to recoup more of its losses before generics enter the market.  (FDA – Innovation Act and PEW Heath Report).  As of October 2013, sixteen antibiotics have been designated as QIDP, with two possibly being approved in 2014. (PEW Heath Report)

Incentivizing antibiotic development may be problematic to implement, primarily because of cost.  We are not used to paying for expensive antibiotics.  A standard course for a current brand-name antibiotic costs around $3,000 per patient.  Compared to current cancer treatments that may cost up to $100,000 per patient, even the most expensive antibiotic is relatively cheap. QIDPs, however, will fall into a category of drugs used to treat rare diseases, which tend to cost nearly $200,000 per patient.  Because QIDPs do not have high potential for profits, the U.S. Government has turned to funding initiatives to assist new antibiotic development.

The FDA’s and CDC’s new policies and Congress’s GAIN Act have already made great steps to encourage the industry to invest in antibiotics.  On July 9, 2013, the FDA issued a proposed rule to establish the “qualifying pathogen” list.  The FDA has granted 24 QIDP designations for upcoming antibiotics.  (FDA Reviewing FDASIA)  Despite these efforts, more can still be done.  The Government needs to create more incentives for the industry to develop these drugs alongside guaranteed moneymakers.  While funding initiatives may encourage pharmaceutical companies, the best encouragement is more likely larger Medicare and insurance reimbursements for existing drugs, granting the industry a better opportunity to remake the money spent in development of the more expensive QIDPs.  (Forbes)  Insurance providers, interest groups, and physicians need to be more active in informing their patients of what to expect from the developing drugs: what the drugs can do, what they cannot do, and just how expensive they are going to be.  In the end, if Margaret Chan is incorrect and this is not the end of the antibiotic era, it is certainly the end of the cheap antibiotic era.

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Belgian Child Euthanasia Bill Sparks Debate

The debate over euthanasia usually revolves around terminally ill adults.  Adults are presumed to be able to make rational, informed decisions about their quality of life and the possibility of ending it.  But in Belgium, this assumption of rationality is being considered in children.

The Belgian Senate approved a bill in December that would allow euthanasia to be administered to a child of any age who repeatedly requests that his or her life be ended.  The bill increases the scope of an existing euthanasia law passed in 2002, which requires that an adult person (1) is competent and conscious, (2) is repeatedly making the request to die, and (3) is suffering unbearably – physically or mentally – as a result of a serious and incurable disorder.  (BBC)  The bill passed in the Belgian Senate would extend the same criteria to children of any age.  There are further restrictions that would apply specifically to children, however:  under the bill, the child must understand what euthanasia is, and their parents and medical teams have to approve the child’s decision to die.  The child must also possess the “capacity of discernment” (a term left undefined in the bill) for his or her request to be considered.  (NYTimes)  The bill next goes to the House of Representatives, where it will likely be enacted.  (USA Today)

In support of the bill, sixteen leading Belgian pediatricians wrote a letter demanding the expansion of euthanasia rights to terminally ill children. They, along with other proponents of the bill, say that giving euthanasia options to terminally ill children is an act of compassion.  Their reasoning is that both children and adults suffer from the same terminal illnesses, so the right to die should equally extend to both groups.  Supporters also claim that terminally ill children are more psychologically mature than their healthy counterparts, which gives them the mental capacity necessary to make such an important decision.  (Deutsche Welle)

Opponents of the bill include religious communities and some bioethics experts.  The Catholic Church has come out in opposition of the bill (USA Today), and an alliance of Catholic, Muslim, Protestant, and Christian Orthodox representatives have published an open letter in opposition.  Carine Brochiner of the European Institute of Bioethics in Brussels equates the right to euthanasia with other rights in Belgium unavailable to children:  “A child cannot buy a house in Belgium.  A child cannot buy alcohol in Belgium.  And this law would allow a child to be killed.  And that is a real problem.”  (Deutsche Welle)  Private citizens are also voicing their opposition. Steve Forbes, the chairman of Forbes Media, published an article calling the practice “HitlerCare.”  (NewsMax)

If the bill passes, Belgium will become the first country to allow euthanasia in children without age restrictions.  Its neighbor to the north, the Netherlands, has long been labeled as the European country most supportive of euthanasia.  The Netherlands became the first country to legalize euthanasia in 2001, and before euthanasia was legalized, the practice was tolerated by government officials.  But even the Netherlands does not allow euthanasia for children under the age of twelve.  (Washington Times)

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