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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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

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

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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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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