The agency plans to take a "multi-pronged approach" to advancing oversight of machine learning-enabled devices – with an eye toward ensuring patient safety, algorithm transparency and real-world results. The AI/ML-Based Software as a Medical Device Action Plan is a project of the Digital Health Center of Excellence at FDA's Center for Devices and Radiological Health, which launched this past September.
"With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime. Ensuring physician-led teams for treating patients with opioid use disorder is critical to ending the opioid epidemic" stated Patrick Harris, Chair of AMA Opioid Task Force.
The authors of the study speculated that increased access to primary care as a result of insurance expansion improved outpatient disease management and reduced asthma exacerbations. Access to insurance allows patients with asthma to reduce their utilization of emergency services through improved control therapy, improved rescue therapy, and increased access to counseling for their disease.
Online medical records (OMRs), sometimes referred to as patient portals, facilitate patients’ access to their health records through secure online platforms and provide individuals with the capability to view, download, and transmit their patient health information. Access to patient portals has been shown to increase patient engagement with their providers, treatment adherence, and overall quality of care.