Healthcare IT Today

JUNE 27, 2023

Food and Drug Administration (FDA) has recognized the problem and issued multiple guidance documents over the years—as recently as this March —to ensure the cybersecurity of medical devices. Although none of the FDA recommendations are legally enforceable, device manufacturers no longer have a choice but to comply.

Ransomware 114

Ransomware FDA Governance Hospitals 114

Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

FDA 40

FDA Public Health Compliance Hospitals 40

HIT Consultant

FEBRUARY 22, 2022

For healthcare consumers, it provides a holistic and comprehensive medical history that is not specific to any healthcare organization or technology and that follows them wherever they go – at a hospital while on vacation, across town to a new provider, or at various specialists. It becomes a tangled web of data points.

Electronic Medical Records 98

Electronic Medical Records Doctors Hospitals FDA 98

Healthcare IT Today

SEPTEMBER 12, 2023

A major justification for President Biden’s tax hike proposal is to shore up the tenuous finances of Medicare whose trust fund is forecasted to be depleted by 2028. Historically, it is the most prolific driver of family bankruptcy, and now it is on its way to bankrupting our country collectively.

Nurses 73

Nurses Doctors Medicare Medicare 73

SQA

OCTOBER 18, 2024

Processes and Practices Applicable to Bioresearch Monitoring Inspections, Draft Guidelines for Industry, 04 June 2024 The FDA is announcing the availability of draft guidelines for industry entitled Processes and Practices Applicable to Bioresearch Monitoring Inspections. The deadline to submit feedback for this plan is 25 July 2024.

FDA 52

FDA Compliance Public Health World Health 52

Healthcare IT Today

MAY 18, 2023

Currently, when hospitals monitor a patient being treated with vancomycin, they take a blood test that requires several hours to return results. Although the treatment regimen calls for testing once or twice a day at very specific times, many hospitals test less often due to workflow and resource constraints. This can save lives.

Doctors 117

Doctors FDA Hospitals Telemedicine 117

SQA

OCTOBER 18, 2024

Processes and Practices Applicable to Bioresearch Monitoring Inspections, Draft Guidelines for Industry, 04 June 2024 The FDA is announcing the availability of draft guidelines for industry entitled Processes and Practices Applicable to Bioresearch Monitoring Inspections. The deadline to submit feedback for this plan is 25 July 2024.

FDA 40

FDA Compliance Public Health Governance 40