FDA Encourages Medical Device Data System Innovation
Medical Device Data Systems Pose Low Risk By Bakul Patel Thanks to advances in digital health, doctors and their patients are more frequently using computer…
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HHS Publishes FDASIA Health IT Report
Food and Drug Administration Safety and Innovation Act By Brian Ahier HHS released a draft report that includes a proposed strategy and recommendations for a…
Patient Information System Recalls
FDA Posts Recall of Computerized Record System William A. Hyman Professor Emeritus, Biomedical Engineering Texas A&M University, w-hyman@tamu.edu Read other articles by this author While EHRs…
Does CDS Need a Regulatory Carve Out?
House Bill to Clarify FDA Regulation on Software COMMENTARY William A. Hyman Professor Emeritus, Biomedical Engineering Texas A&M University, w-hyman@tamu.edu Read other articles by this author…
mHealth Guidance Released by FDA: Let’s Boldly Go
FDA to Exercise Enforcement Discretion Kathy McCoy, MBA Follow her on Twitter @kathymccoy I’ll just admit it right now: I’ve been a fan of Star…
Are You Getting Good Advice from Your Clinical Decision Support Systems?
Electronic Bad Advice COMMENTARY William A. Hyman Professor Emeritus, Biomedical Engineering Texas A&M University, w-hyman@tamu.edu Read other articles by this author Meaningful Use requires the…
FDA Warning on Medical Devices
Q&A with Mac McMillan Mac McMillan, chair of the HIMSS Privacy & Security Task Force and CEO of CynergisTek answers questions for us on the…
EHR and Cyber Security
COMMENTARY William A. Hyman Professor Emeritus, Biomedical Engineering Texas A&M University, w-hyman@tamu.edu Read other articles by this author The FDA has issued a draft guidance…
Will UDI Capability Be Incorporated into EHR Certification?
EHR Meets UDI COMMENTARY William A. Hyman Professor Emeritus, Biomedical Engineering Texas A&M University, w-hyman@tamu.edu Read other articles by this author Unique Device Identification (UDI) is a…