Rainbow lgbtq pride flag and trans pride flag.

Sexual Orientation and Gender Identity in Medical Records Can Reduce Disparities

By Jenna Becker

Sexual orientation and gender identity (SOGI) data is widely considered crucial to providing competent care to LGBTQ+ patients. This data can also be used to reduce health disparities among sexual and gender minority populations.

Most electronic health record (EHR) vendors are able to document SOGI data. Many health care systems across the country have been collecting SOGI information for several years. However, SOGI documentation is not broadly required. It’s time to require SOGI data collection in EHRs nationwide.

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A calculator, a stethoscope, and a stack of money rest on a table.

Telemedicine is No Cure for Fraud and Abuse

By Vrushab Gowda

The exponential growth of telehealth in recent years has revolutionized the delivery, access, and cost of care. Unfortunately, it is not immune to the fraud and abuse that divert nearly $70 billion from the health care system annually.

A rise in suspect practices has been accompanied by a concomitant escalation of Department of Justice (DOJ) enforcement, sending a clear signal to would-be fraudulent actors.

The ongoing Operation Rubber Stamp is one such enforcement thrust. A joint initiative of the of the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS), it targeted an extensive network of telemedicine fraud totaling over $4.5 billion in false claims and yielding thirty guilty pleas to date.

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computer and stethoscope

Is Real-World Health Algorithm Review Worth the Hassle?

By Jenna Becker

The U.S. Food and Drug Administration (FDA) should not delay their plans to regulate clinical algorithms, despite challenges associated with reviewing the real-world performance of these products. 

The FDA Software Pre-Certification (Pre-Cert) Pilot Program was designed to provide “streamlined and efficient” regulatory oversight of Software as a Medical Device (SaMD) — software products that are regulable by the FDA as a medical device. The Pre-Cert program, in its pilot phase, is intended to inform the development of a future SaMD regulatory model.

Last month, the FDA released an update on Pre-Cert, highlighting lessons learned from pilot testing and next steps for developing the program. One key lesson learned was the difficulty in identifying and obtaining the real-world performance data needed to analyze the clinical effectiveness of SaMDs in practice. Although this challenge will be difficult to overcome in the near future, the FDA’s plans to regulate should not be slowed by insufficient postmarket data.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

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Photograph of a doctor holding a headset sitting in front of a laptop

How Telehealth Can Reduce Disparities

By Jenna Becker

Telehealth can and should be used in an intentional effort to reduce health disparities.

Increased COVID-19 mortality rates in communities of color have been a constant, tragic reminder of the ways in which systemic racism causes poor health outcomes in the United States. Immigrants are facing an increased risk of illness and limited access to care. Rural Americans may face an increased risk of serious illness.

Telehealth can reduce barriers to care that these groups face, such as lack of access to transportation, culturally-competent providers, and childcare.

The last six months have seen rapid growth in the use of telemedicine in response to the COVID-19 pandemic. In response to urgent need, regulatory agencies and private insurance companies have loosened requirements that previously inhibited the use of telehealth.

The expansion of telehealth and removal of traditional barriers to care may lead to more equitable health outcomes.

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Cartoon of contact tracing for COVID-19.

COVID-19, Misinformation, and the Law in Nigeria

By Cheluchi Onyemelukwe

The spread of COVID-19 in Nigeria has been paralleled by the spread of misinformation and disinformation about the novel coronavirus. In Nigeria, information casting doubt on the existence of the coronavirus is spread especially through social media channels, but also through other informal channels.

Some religious leaders with considerable influence have doubted the existence of the virus, and shared conspiracy theories on its origins and the interventions instituted to prevent further spread of the virus. Others have taken to social media to express concerns about the Nigerian government and a perceived lack of transparency. For example, the government has received criticism for continuing its school feeding program during the pandemic, at a time when schools are closed, children are at home, and the country’s financial resources are scarce.

Unproven cures and interventions are also regularly propagated, especially via social media channels such as WhatsApp. For instance, hydroxychloroquine, a drug used for malaria previously, has been touted as a cure, despite evidence to the contrary, prompting some to stockpile it and instigating much discussion on social media.

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stethoscope on computer keyboard

How Traditional Health Records Bolster Structural Racism

By Adrian Gropper, MD

As the U.S. reckons with centuries of structural racism, an important step toward making health care more equitable will require transferring control of health records to patients and patient groups.

The Black Lives Matter movement calls upon us to review racism in all aspects of social policy, from law enforcement to health. Statistics show that Black Americans are at higher risk of dying from COVID-19. The reasons for these disparities are not entirely clear. Every obstacle to data collection makes it that much harder to find a rational solution, thereby increasing the death toll.

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A frustrated woman sits at her desk, staring at her computer. Her head is resting in her hand

Patient-Directed Uses vs. The Platform

By Adrian Gropper, MD

This post originally appeared on The Health Care Blog.

This piece is part of the series “The Health Data Goldilocks Dilemma: Sharing? Privacy? Both?” which explores whether it’s possible to advance interoperability while maintaining privacy. Check out other pieces in the series here.

It’s 2023. Alice, a patient at Ascension Seton Medical Center Austin, decides to get a second opinion at Mayo Clinic. She’s heard great things about Mayo’s collaboration with Google that everyone calls “The Platform”. Alice is worried, and hoping Mayo’s version of Dr. Google says something more than Ascension’s version of Dr. Google. Is her Ascension doctor also using The Platform?

Alice makes an appointment in the breast cancer practice using the Mayo patient portal. Mayo asks permission to access her health records. Alice is offered two choices, one uses HIPAA without her consent and the other is under her control. Her choice is: Read More

Illustration of a man and a woman standing in front of a DNA helix

The End of Privacy?

By Rachele Hendricks-Sturrup

“Any idea we had about privacy is over,” says Dr. Julia Creet, leading international scholar in Cultural Memory Studies, Professor of English at York University, and author of the upcoming book, The Genealogical Sublime. In 2017, Dr. Creet received a York Research Leader Award in part for her investigative work and documentary entitled, “Data Mining the Deceased: Ancestry and the Business of Family,” which received critical acclaim and is streaming on demand in the U.S., Canada, and abroad. Dr. Creet also received a York President’s Research Impact Award in 2019 for her research on digital privacy, data mining, genealogy, and memory.

Dr. Creet’s work builds on Bill of Health’s key ethical and legal discussions around the direct-to-consumer (DTC) genetic testing and health data privacy. Dr. Rachele Hendricks-Sturrup, genetics and privacy scholar and research fellow at Harvard Pilgrim Health Care Institute and health policy counsel at the Future of Privacy Forum, recently sat down with Dr. Creet to discuss emerging issues and concerns about genetic privacy (or a perceived lack thereof) in an increasing information and genealogical age. The following interview has been edited for length and clarity.

 

Dr. Rachele Hendricks-Sturrup: Regarding genealogical recording in the era on increasing DTC genetic testing, you’ve mentioned in your upcoming book, “Any idea we had about privacy is over.” Tell us a little more about your thoughts here. Read More

DNA sequence

How the Internet and The Mapping of the Human Genome Disrupted the Teaching of Health Law: Does The 21st Century Really Change Everything?

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the forthcoming issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In her post for the Promises and Perils of Emerging Health Innovations blog symposium, Jennifer S. Bard addresses many of the negative impacts of new health technologies, particularly as they apply to patient privacy. Bard points to special concerns in how we use health information related to DNA, mental health, and chronic illness. Throughout her piece, Bard also highlights the fact that law has not caught up to changes in technology and privacy issues, which causes more concern about how society and the healthcare system use these innovations.

How the Internet and The Mapping of the Human Genome Disrupted the Teaching of Health Law: Does The 21st Century Really Change Everything?

By Jennifer S. Bard

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