Authors

Jenna Becker is a 2L at Harvard Law School with a background in healthcare software.
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Health Care AI in Pandemic Times

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By Jenna Becker

The early days of the COVID-19 pandemic was met by the rapid rollout of artificial intelligence tools to diagnose the disease and identify patients at risk of worsening illness in health care settings.

Understandably, these tools generally were released without regulatory oversight, and some models were deployed prior to peer review. However, even after several months of ongoing use, several AI developers still have not shared their testing results for external review. 

This precedent set by the pandemic may have a lasting — and potentially harmful — impact on the oversight of health care AI.

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Rise in Hospital Ransomware Attacks Requires Government Intervention

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By Jenna Becker

Last week, widespread ransomware attacks against hospital systems forced several hospitals to go offline. 

Despite the growing risk of cyberattacks against hospitals, the health care industry has been left to address this issue on their own. Ransomware attacks, named for the fee that these malicious viruses attempt to extract, can be very challenging to address, involving complex cybersecurity protocols.

Unfortunately, many hospitals lack the resources and the time required to prevent this malware from spreading. The government has provided minimal resources to hospital systems looking to enhance their cybersecurity. Resource-strapped hospitals require significant government support to address the growing threat of ransomware.

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Sexual Orientation and Gender Identity in Medical Records Can Reduce Disparities

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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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Is Real-World Health Algorithm Review Worth the Hassle?

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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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Insufficient Protections for Health Data Privacy: Lessons from Dinerstein v. Google

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By Jenna Becker

A data privacy lawsuit against the University of Chicago Medical Center and Google was recently dismissed, demonstrating the difficulty of pursuing claims against hospitals that share patient data with tech companies.

Patient data sharing between health systems and large software companies is becoming increasingly common as these organizations chase the potential of artificial intelligence and machine learning in healthcare. However, many tech firms also own troves of consumer data, and these companies may be able to match up “de-identified” patient records with a patient’s identity.

Scholars, privacy advocates, and lawmakers have argued that HIPAA is inadequate in the current landscape. Dinerstein v. Google is a clear reminder that both HIPAA and contract law are insufficient for handling these types of privacy violations. Patients are left seemingly defenseless against their most personal information being shared without their meaningful consent.

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How Telehealth Can Reduce Disparities

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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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