Former first lady Laura Bush published an op-ed in the Washington Post where she reminded us that today’s mass detention centers for children whose parents are accused of illegally crossing the border is a public health crisis — one we have seen before.
Privacy, especially as it relates to healthcare and protecting sensitive medical information, is an important issue. The Health Insurance Portability and Accountability Act, better know as HIPAA, is a legislative action that helps to safeguard personal medical information. This protection is afforded to individuals by the Privacy Rule, which dictates who can access an individual’s medical records, and the Security Rule, which ensures that electronic medical records are protected.
Access to someone’s healthcare records by a medical provider typically requires a direct health care-related relationship with the patient in question. For example, if you have a regular doctor, that doctor can access your medical records. Similarly, if you call your doctor’s office off-hours, the covering doctor, whom may have no prior relationship with you, may similarly access these records. The same holds true if you go to the emergency department or see a specialist. No provider should be accessing protected information however, without a medical need.
By Ryan J. Duplechin
As waves of opioid lawsuits have mounted in the federal courts, one district court was chosen to shepherd all the cases, and one judge is motivated to step up to stem the tide of the epidemic.
In the Northern District of Ohio, Judge Dan A. Polster was chosen by the Judicial Panel on Multidistrict Litigation, which centralized hundreds of suits, and created the Opioid MDL.
“The federal court is probably the least likely branch of government to try and tackle [the opioid epidemic], but candidly, the other branches of government, federal and state, have punted,” said Judge Polster during the first hearing of the MDL in January. “My objective is to do something meaningful to abate this crisis and to do it in 2018.”
By Alex Pearlman and Jonathan Darrow
Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources differently.
By James Love
The Senate HELP committee held a hearing on June 12 on “The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices” where Secretary Alex Azar was the sole witness.
It was a moment for the Democrats in the Senate to draw a sharp contrast with the Trump Administration on an issue voters care about: drug prices.
By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit
A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.
Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.
An earlier version of this article was published in STAT.
The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.
DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Continue reading
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.
Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted.
Such efforts hold great promise, but also raise potential challenges for ethical oversight.
How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups?
This symposium will bring together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.
By Gali Katznelson
Recently there has been a shift in popular parlance toward referring to PCPs as primary health care providers. Not primary health care physicians or practitioners, but providers.
This change seems to have increased in popularity after the original passage of the ACA, specifically with the opening of the health insurance marketplaces.
But it was particularly jarring, as a Canadian, to become accustomed to terminology that reframes physicians as providers, and patients as consumers.
Ostensibly, this language comes from a movement to empower patients to be more engaged in their health care rather than to accept passively that the “doctor knows best.” It is an effort to shift away from health care delivery by paternalistic doctors of the past, and toward the contemporary active patients who take ownership of their health and participate in making decisions. As a result, doctors are framed as service providers who cater to the needs of their consumers.
But we must challenge this narrative.
By Stephen P. Wood
The opioid epidemic and the toll it is taking is on American lives has resulted in the declaration of a public health emergency by the Trump administration.
There were 42,000 deaths from suspected opioid overdose in 2016, more than in any previous year to date. These deaths illuminate the direct impact of the epidemic, but this is only the tip of the iceberg. Hepatitis C is another epidemic that goes increasingly hand-in-hand with the opioid crisis, and is likely to take a long-term toll on American lives as well. Intravenous drug use accounts for approximately 80 percent of new cases of hepatitis C virus (HCV) infection in the United States, and without intervention these numbers could continue to climb. Continue reading
By John Tingle
In the UK, emergency and urgent care patients visit the A & E (Accident and Emergency) units of local hospitals (known as ERs in the U.S.) A & E service provision is the public face of the NHS. It is seen by many as the bellwether of the national health care system and the basis on which its performance is judged.
The Health and Social Care Regulator of England, the Care Quality Commission (CQC), which maintains important patient safety and health quality reviews, has recently published a report on A & E urgent care that found that the 2017-2018 winter season saw an unprecedented demand for emergency services, continuing a year-over-year increase. The number of emergency admissions has grown by 42 percent over the last 12 years, adding pressure to the NHS.
By Sara Gerke
This new working group, known as ELSA, focuses on the ethical, legal and social aspects of the modern life sciences. ELSA aims to serve as a country-wide interdisciplinary platform for the exchange of information and for the analysis and discussion of challenges facing basic and applied stem cell research in Germany.
In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.
In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.” Ultimately, Rivera received a living donor kidney transplant from her mother.
At last week’s Petrie-Flom Center Annual Conference, “Beyond Disadvantage: Disability, Law, and Bioethics,” discussed a number of topics related to the “mere difference” vs. “bad difference” disability theory debate.
Over the course of the day, six panels of experts shared their research and views on topics ranging from health care as eugenics to epistemic injustice to organ donation.
We will have the videos of the event soon, but in the meantime, enjoy the tweets from #rethinkingdisability and some photos from throughout the day by photographer Martha Stewart.
This week on the pod I welcome Amy McGuire, the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine and Natalie Ram, a Professor of Law at The University of Baltimore School of Law. Our conversation revolves around the arrest of the suspected Golden State Killer who was partially identified by a DNA match through a publicly accessible database. Legal topics range from the Fourth Amendment to HIPAA and the Common Rule as we discuss implications for personal privacy and major, DNA-led projects such as Precision Medicine. For background see this and this.
By Stephen P. Wood
Naloxone is an opioid-receptor antagonist. In other words, it has the ability to displace an opioid from the receptor site, and essentially reverse its activity to save overdose victims. However, a significant increase in the cost of naloxone has put it out of reach of the people who need it most.
By Paulchris Okpala
Do the provisions of the 2008 Americans with Disabilities Act Amendments Act (ADAAA) address challenges faced by medical professionals with disabilities (MPD)?
A 2012 report on Americans with disabilities from the US Census Bureau suggests that it is highly unlikely. There is every reason to be alarmed by the increasing number of medical professionals with disabilities who leave their jobs, or express the intention to quit employment. There is also a rapidly decreasing number of MPD who express the desire to seek employment. Could this trend be attributed to the challenges faced by the MPD in the workplace?
By Rebecca Dresser
Anyone fortunate enough to live beyond middle age faces a risk of developing dementia. Dementia is a widely feared disability. People often say they wouldn’t want to live if they developed the condition.
Experts in law and ethics praise advance directives, or instructions to follow on behalf of patients, as a tool giving people control over the life-sustaining medical care they later receive as mentally impaired dementia patients. Some advance directive supporters also want the law to recognize advance requests to withhold ordinary food and water in the late stages of dementia. And some argue that the U.S. should follow the Netherlands in allowing doctors to give lethal drugs to people who made advance directives asking for assisted death if dementia makes them unable to live at home or to recognize their loved ones.
By Sara Gerke
The EU’s General Data Protection Regulation, which came into force two years ago but became directly applicable in all EU Member States only last week, aims to establish an equal level of protection for the rights and freedoms of natural persons with regard to the processing of personal data in all EU Member States.
According to its territorial scope, the GDPR can also impact US companies that process personal data of data subjects who are in the EU. For example, this is the case for newspapers and affiliated websites, where the processing activities are related to the offering of services or goods, irrespective of whether payment is required. Some papers decided to simply block users in the EU, rather than abide by the GDPR’s provisions.