Category: Patient Care

Judge's gavel, handcuffs and scales on grey background, flat lay with space for text. Criminal law concept.

Seven Opportunities to Use the Law to Address Drug Policing

Temple University Center for Public Health Law Research Leave a comment

By Jon Larsen and Sterling Johnson

There is a well-established whole of government response to drug policing centered around the “war on drugs.” However, the existing response is largely built on flawed policies that have resulted in mass incarceration, structural racism, and lagging improvements in treatment and harm reduction related to the opioid crisis. Policy changes must be considered to replace acknowledged failures and reimagine the whole of government response to drug policing. 

With support from the Foundation for Opioid Response Efforts (FORE), public health law experts from Indiana University McKinney School of Law and the Temple University Center for Public Health Law Research at the Beasley School of Law recently embarked on a systematic review of US drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). It ultimately provides a tool to address these misalignments directly. 

Read More

A surveillance camera on a white background.

Combatting Elder Abuse in Long-Term Care: Challenges and Opportunities of Electronic Monitoring

The Petrie-Flom Center Staff Leave a comment

By Laura C. Hoffman

The aging population is growing at an extraordinary rate in the U.S. By 2040, it is anticipated that the U.S. aging population (defined as those ages 65 and older) will double, totaling 80 million.

Given this growth, preventing elder abuse must be at the forefront of policymaking. The U.S. Centers for Disease Control and Prevention (CDC) has recognized elder abuse as a “serious” problem that is commonly occurring, yet significantly underreported, in the U.S.

Read More

Close-up Of An Open Law Book On Wooden Desk In Courtroom.

Can Rights Make Any Difference for Access to Health? Insights from a Scoping Review on Constitutional Rights for the WHO Council on the Economics of Health for All

Luciano Bottini Filho Leave a comment

By Luciano Bottini Filho, Camila Gianella Malca, and Alicia Ely Yamin

The intersection of health financing and the right to health is a common concern in public health advocacy. However, it is challenging to isolate the mechanisms that connect individuals’ rights with increased public investment. As scholars, we grapple with the question of what happens once the right to health is constitutionalized and whether it has a transformative effect on the economy, government funding, and the material reality people face in struggling health care systems. In this article, we shed light on this significant gap between the adoption of the right to health through constitutions or legislation and actual changes in the economy and government funding for health. Our study was commissioned by the WHO Council on the Economics of Health for All, which received the mandate of formulating a new global economic model to achieve health for all.

Read More

Shot of a landline telephone receiver hanging upside down.

Addressing Ghost Networks in Mental Health Care

Hannah Rahim Leave a comment

By Hannah Rahim

Many mental health provider directories for private and public insurance plans contain inaccurate or outdated provider information, which creates a misleading illusion of accessible care. These ghost networks result in many patients being unable to access essential mental health care. To tackle this issue, federal and state governments should strengthen the regulation of insurance networks and insurers should address underlying causes of inadequate networks.

Read More

Person hands keys into another person's outstretched hand.

We May Not ‘Own’ Our Bodies. Should We?

Adithi Iyer Leave a comment

By Adithi Iyer

As the provision of human tissue leaves the research realm and becomes a bona fide consumer transaction, our legal responses to these developments will be most effective when we know what we want to protect, and how.

Perhaps the most famous discussion around tissue “donation” comes from the story of Henrietta Lacks and her family. Ms. Lacks is the namesake and unknowing donor of HeLa cells, and subject of the Rebecca Skloot bestseller, The Immortal Life of Henrietta Lacks. In a settlement obtained just this past summer with manufacturing giant ThermoFisher, the Lacks estate (Ms. Lacks herself died of an aggressive cervical cancer in 1951) obtained a confidential payment for the unconsented taking of her cells for research. The settled case was built on an unjust enrichment claim, and while this wasn’t decided on the merits, it raises the question of whether a provision of tissue is a transfer of value. If so, what are our ownership stakes in that value? Read More

President Joe Biden at desk in Oval Office.

What’s on the Horizon for Health and Biotech with the AI Executive Order

Adithi Iyer Leave a comment

By Adithi Iyer

Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). One such sector (mentioned, from my search, 33 times) is health/care. This is perhaps unsurprising— the health sector touches almost every other aspect of American life, and of course continues to intersect heavily with technological developments. AI is particularly paradigm-shifting here: the technology already advances existing capabilities in analytics, diagnostics, and treatment development exponentially. This Executive Order is, therefore, as important a development for health care practitioners and researchers as it is for legal experts. Here are some intriguing takeaways:  Read More

Suboxone.

Five Opportunities to Use the Law to Address Persistent OUD Treatment Gaps 

Temple University Center for Public Health Law Research Leave a comment

By Jon Larsen and Sterling Johnson

People who need opioid use (OUD) treatment in the United States are often not receiving it — at least two million people with OUD are experiencing a treatment gap that prevents or hampers their ability to receive life-saving care and support. This reality reflects structural, policy, and legal misalignments common to the entire U.S. health care system, but that are especially present for behavioral health needs like substance use, and are exacerbated by other challenges related to stigma, lack of employment, and fragmented or nonexistent care coordination.  

With support from the Foundation for Opioid Response Efforts (FORE), public health law experts from Indiana University McKinney School of Law and the Temple University Center for Public Health Law Research at the Beasley School of Law recently embarked on a systematic review of U.S. drug policy using a whole-of-government (W-G) approach to assess where these misalignments are occurring among different agencies at the same level of government (referred to as horizontal W-G), and across different levels of government (referred to as vertical W-G). It ultimately provides a tool to address these misalignments directly. 

Read More

City with trash in foreground and smokestacks producing smog in background.

The Privatization of Cancer

Daniel G. Aaron 2 Comments

By Daniel G. Aaron

Cancer is fearsome, unstoppable even. So the story goes. Yes, you can secure some extra time with loved ones, and — if you are lucky —  maybe your cancer is susceptible to drugs or surgery. But for most people, cancer sounds like a death sentence. The proper response is to throw drugs and radiation at it.

Cancer seems so unstoppable that many have started rifling through their cosmetic products and foods to eliminate all possible carcinogens. Despite the fact we have regulatory regimes to ensure our food, makeup, the air, and drinking water are free of carcinogens, people don’t trust them. There is an intuitive sense that products are not well regulated, leaving individuals to moderate their own cancer risk. In fact, the majority of Americans do not hold strong trust in our health agencies like FDA and CDC.

In my forthcoming article, I argue that our cancer regulatory regimes inadequately protect the public. I believe deregulation is one form of the “privatization of cancer.”

Read More

Doctor asking patient to fill out survey before medical treatment.

Key Considerations for Patient-Reported Outcome Measures

The Petrie-Flom Center Staff Leave a comment

By Sharona Hoffman

Patient-reported outcome measures (PROMs) are questionnaires that patients fill out on tablets or other computers or devices. They ask patients to check boxes in answer to questions about their symptoms, treatment effects, and ability to function physically, emotionally, and socially. They thus may solicit very sensitive information about matters such as anxiety, depression, and sexual satisfaction. To illustrate, a query might be “in the past month, how often did you have a lot of trouble falling asleep,” and the patient is asked to check “never,” “rarely,” “sometimes,” “often,” or “always.”

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. For example, insurers hypothetically could decide to decline coverage of particular treatments based on PROM responses indicating that many patients find them to be unhelpful.

I first became interested in patient-reported outcome measures because of an experience my husband had. Andy has Parkinson’s disease, and one of the neurologists he saw asked him to fill out a long questionnaire on a tablet computer before each appointment. This task was difficult for Andy because he had a hand tremor, and it was stressful because Andy worried that he would not have time to complete the survey before his appointment began. Moreover, Andy’s physician never referred to his responses and appeared never to look at them. Upon investigation, I found little to no analysis of PROMs in the legal literature, so Andy and I recently published a law review article about them.

Read More

Operating room Doctor or Surgeon anatomy on Advanced robotic surgery machine.

Protecting Consumer Privacy in DTC Tissue Testing

Adithi Iyer Leave a comment

By Adithi Iyer

In my last piece, I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Now, as promised, a closer look at the “who” and “how” of protecting the consumer at the heart of direct-to-consumer precision medicine. While several potential consumer interests are at stake with these services, at top of mind is data privacy — especially when the data is medically relevant and incredibly difficult to truly de-anonymize.

As we’ve established, the data collected by a tissue-based service will be vaster and more varied than we’ve seen before, magnifying existing issues with traditional data privacy. Consumer protections for this type of information are, in a word, complicated. A singular “authority” for data privacy does not exist in the United States, instead being spread among individual state data privacy statutes and regulatory backstops (with overlapping sections of some federal statutes in the background). In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled.

Read More