Should We Regulate Direct-to-Consumer Health Apps?
Over 318,000 health apps are available in app stores, but only a fraction are regulated by the U.S. Food and Drug Administration.
Regulation
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Read more: Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling
The court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision.
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Read more: We Need to Do More with Hospitals’ Data, But There Are Better Ways We Need to Do More with Hospitals’ Data, But There Are Better Ways
Health systems are hoping to leverage the know-how of tech titans to unlock the potential of their treasure troves of data.
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Read more: Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal
As has been proven time and again, “gut feeling” and wishful thinking have never been shown to replace controlled clinical testing.
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Read more: Top Health Considerations in the European Commission’s ‘Harmonised Rules on Artificial Intelligence’ Top Health Considerations in the European Commission’s ‘Harmonised Rules on Artificial Intelligence’
On April 21, 2021, the European Commission released a “first-ever” legal framework on artificial intelligence.
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Read more: Regulatory Gap in Health Tech: Resource Allocation Algorithms Regulatory Gap in Health Tech: Resource Allocation Algorithms
Resource allocation algorithms have received less regulatory attention than clinical decision-making algorithms, but nevertheless pose similar concerns.
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Read more: Challenges in COVID-19 Vaccine Rollout: Lessons from the UK Challenges in COVID-19 Vaccine Rollout: Lessons from the UK
The U.S. can and should cautiously assess the U.K.’s vaccination strategy to avoid challenges that may impede its ability to control the virus.
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Read more: Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines
The EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.
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Read more: A Dose of Perspective on World Patient Safety Day A Dose of Perspective on World Patient Safety Day
We should not forget that all is not well at home, and that some systems are failing, causing avoidable patient injury, and, in some cases, death.
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Read more: Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson
In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.
