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.
Midterm Takeaways Director’s Cut: I am joined by Professor Wendy Mariner, Professor of Health Law at Boston University School of Public Health and Professor of Law at Boston University School of Law. It was three days after the midterm elections and we thought it would be a good idea to reflect on some of the health law and policy stories. Here’s the complete list.
The Trump Administration launched the largest healthcare fraud takedown in history in June, charging over 600 individuals responsible for over $2 billion in fraud losses. This takedown, along with the previous summer’s (which had previously been the largest when it happened) has allayed concerns that the Justice Department would ease off healthcare fraud prosecutions as a form of white-collar, rather than violent, crime.
Indeed, former Attorney General Sessions committed to aggressive prosecution of healthcare fraud as part of the Administration’s response to the opioid epidemic. One change does seem clear, however: the Administration is prioritizing the prosecution of individuals, and scaling back on the prosecution of corporations. Read More
San Pedro Sula in Honduras was the murder capital of the world for decades, a title it lost only a few years ago to Caracas, Venezuela in 2016.
At its peak, there were an average of three murders a day, which is alarming for a city with a census population of around only 765,000. This violence is fueled by a booming drug and weapons trade, one-third of the population facing unemployment, the presence of violent gangs, and political strife that make living in Honduras a daily life or death struggle.
When framed this way, it is clear to see that the term “migrant caravan” doesn’t at all describe this group marching from Honduras, through Mexico to the United States border. Let’s not let politicos or the media brand them as anything else. Terminology is important here, and the term “migrant caravan” doesn’t even begin to describe this group.These people are victims of torture, fleeing a violent landscape to seek asylum for themselves and their families. Anything less than that is a disgraceful mischaracterization of who they actually are.
Health care issues were a major driver of voting across the country this week. Here are some key takeaways from the health-related ballot measures and newly elected candidates that emerged from Tuesday’s election.
Machine learning in medicine is accelerating at an incredible rate, bringing a new era of ethical and regulatory challenges to the clinic.
In a new paper published in PLOS Medicine, Effy Vayena, Alessandro Blasimme, and I. Glenn Cohen spell out these ethical challenges and offer suggestions for how Institutional Review Boards (IRBs), medical practitioners, and developers can ethically deploy machine learning in medicine (MLm). Read More
Eight in ten Americans think that prescription drug prices are unreasonable, according to a March 2018 Kaiser poll. That same poll found that more Americans considered passing legislation to lower drug pricing to be a top priority than passing legislation to improve infrastructure or to address the prescription painkiller epidemic, among other things.
Effectively addressing drug pricing is a complex task that will require the diligent efforts of many actors. On October 24, the Petrie-Flom Center held a full day’s programming to this important and timely topic. What I want to state here is a simple point—namely, that the very discussion of potential solutions can play a role in turning creative innovations into implementable solutions.
At the end of last month, the New York Times reported on a leaked internal memorandum from Health and Human Services proposing to narrowly define “sex” as “biological sex,” a move made with the purpose of excluding transgender people from a variety of civil rights protections.
The memorandum stirred concerns about the future of Section 1557 of the Affordable Care Act, which provides for an anti-discrimination cause of action in health care settings and has been the basis of a number of private lawsuits by transgender patients. The HHS memorandum reinforces that the Trump administration plans to reinterpret Section 1557 to stem this litigation.
At the end of September, the Senate passed a final version of an expansive legislative package designed to tackle the United States opioid epidemic. The package contains a broad range of policy approaches to the crisis, including enhanced tracking of fentanyl in the U.S. mail system, improved access to Medication Assisted Treatment and addiction specialists, and lifted restrictions on telemedicine and inpatient addiction treatment. The package, which now sits on President Trump’s desk, is widely expected to be signed into law.
The legislative effort has been lauded as a rare act of bipartisanship in an otherwise-polarized Washington.
The Washington Post called the set of bills “one of the only major pieces of legislation Congress is expected to pass this year.” A Time headline declared that “Opioid Bill Shows Congress Can Still Work Together.” Praise of this across-the-aisle effort is merited: the Senate voted for the set of bills 98-1, and the House voted for it 393-8.
While critics have rightfully pointed out that the package does not provide for enough increased spending to address the crisis, with more than 72,000 people dying from drug overdoses in 2017, the time is ripe for a collaborative approach to the opioid crisis, and any effort helps.
Suicide is a global problem that causes 800,000 deaths per year worldwide. In the United States, suicide rates rose by 25 percent in the past two decades, and suicide now kills 45,000 Americans each year, which is more than auto accidents or homicides.
Traditional methods of predicting suicide, such as questionnaires administered by doctors, are notoriously inaccurate. Hoping to save lives by predicting suicide more accurately, hospitals, governments, and internet companies are developing artificial intelligence (AI) based prediction tools. This essay analyzes the risks these systems pose to safety, privacy, and autonomy, which have been under-explored.
Two parallel tracks of AI-based suicide prediction have emerged.
The first, which I call “medical suicide prediction,” uses AI to analyze patient records. Medical suicide prediction is not yet widely used, aside from one program at the Department of Veterans Affairs (VA). Because medical suicide prediction occurs within the healthcare context, it is subject to federal laws, such as HIPAA, which protects the privacy and security of patient information, and the Federal Common Rule, which protects human research subjects.
My focus here is on the second track of AI-based suicide prediction, which I call “social suicide prediction.” Though essentially unregulated, social suicide prediction uses behavioral data mined from consumers’ digital interactions. The companies involved, which include large internet platforms such as Facebook and Twitter, are not generally subject to HIPAA’s privacy regulations, principles of medical ethics, or rules governing research on human subjects.