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Articles by Jeanna D. Blitz
Validating AI in health care: the role of real-world evidence
Before complex medical interventions ever reach patients, their effectiveness must be scientifically proven through rigorous testing in controlled settings such as laboratories and research facilities. But ensuring effectiveness doesn’t stop there. The process of assessing a medical treatment’s usefulness is multilayered and requires investigation that goes well beyond the laboratory. It must also assess how the treatment fares in day-to-day clinical practice for a wide variety of patients.
Artificial intelligence in health care: What your patients want to know Original
Most patients feel it is important to be informed when artificial intelligence (AI) will play a role in their care. Although most anticipate that AI will make health care at least somewhat better in the next five years, many express concerns about misdiagnosis, privacy breaches, unintended consequences of AI, and increased costs. These mixed feelings highlight the importance of addressing patient concerns and providing clear, accessible information.
Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices
As of October 2023, the FDA had identified 692 artificial intelligence/machine learning-enabled products that received clearance for marketing, with sustained growth projected for both submission volume and model diversity.1 Thus, an understanding and appreciation for the expectations and category-specific considerations for these novel medical devices is needed to best navigate the regulatory hurdles on the pathway to approval.
Use of Preoperative Testing and Physicians’ Response to Professional Society Guidance
Importance The value of routine preoperative testing before most surgical procedures is widely considered to be low. To improve the quality of preoperative care and reduce waste, 2 professional societies released guidance on use of routine preoperative testing in 2002, but researchers and policymakers remain concerned about the health and cost burden of low-value care in the preoperative setting.
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