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Category Archives: Medicine

FDA Guidance – Postmarket Management of Cybersecurity in Medical Devices

Draft Guidance for Industry and Food and Drug Administration Staff – Postmarket Management of  Cybersecurity in Medical Devices – This guidance document is being distributed for comment purposes only. Document issued on: January 22, 2016.

“FDA is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to the safety and  effectiveness of medical devices and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health…”

Best Practices for Reducing Near-Road Pollution Exposure at Schools

EPA – Best Practices for Reducing Near-Road Air Pollution Exposure at Schools “Motor vehicles are a major source of air pollution in the United States. Research suggests that particulate matter (PM) from vehicles, notably heavy-duty diesel vehicles, may be especially harmful. While vehicle emissions have decreased over the past several decades due to EPA’s emissionsContinue Reading

Paper on Tuberculosis Knowledge, Awareness and Stigma

Tuberculosis Knowledge, Awareness, and Stigma Among African-Americans in Three Southeastern Counties in the USA: a Qualitative Study of Community Perspectives Rachel A. Royce et al.  Journal of Racial and Ethnic Health Disparities, 1-12. “To inform strategies to address the tuberculosis (TB) excess among US-born African-Americans, we sought to understand the TB experience in the most highly affectedContinue Reading

Medicare to Cover End-of-Life Counseling

The National Acadmies of Sciences, Engineering, and Medicine: “The Centers for Medicare & Medicaid Services (CMS) announced a ruling in July 2015 to pay doctors to counsel patients about end-of-life care or “advance care planning,” a term meant to reflect that people should make their end-of-life wishes known as early as when they get aContinue Reading

GAO Reports – Drug Safety, Emerging Animal Diseases, Federally Leased Vehicles, National Park Service, 2015 Tax Filing Season

Drug Safety: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement, GAO-16-192: Published: Dec 15, 2015. Publicly Released: Jan 14, 2016. Emerging Animal Diseases: Actions Needed to Better Position USDA to Address Future Risks, GAO-16-132: Published: Dec 15, 2015. Publicly Released: Jan 14, 2016. Federally Leased Vehicles: Agencies Should Strengthen Assessment Processes toContinue Reading

GAO Reports – Drug Compounding for Animals, Troubled Asset Relief Program

Drug Compounding for Animals: FDA Could Improve Oversight with Better Information and Guidance [Reissued on January 8, 2016, GAO-15-671: Published: Sep 28, 2015. Publicly Released: Sep 28, 2015: ” Drugs compounded for animals offer certain medical benefits but also pose risks of causing harm or being ineffective. Specifically, drugs compounded for animals can serve asContinue Reading

The Search Engine for Medicine

“At MedNexus [beta] we believe having access to the right medical information can change someone’s life. Exciting new research developments are happening every day but patients (and doctors) are inundated with information and cannot keep up with the latest evidence. MedNexus is a medical search engine for patients – think “Google for Medicine”. Through ourContinue Reading

Report – Violations of Health Privacy Law Common Widespread and Unchecked

Research and reporting by ProPublica and NPR: “CVS is among hundreds of health providers nationwide that repeatedly violated the federal patient privacy law known as HIPAA between 2011 and 2014, a ProPublica analysis of federal data shows. Other well-known repeat offenders include the U.S. Department of Veterans Affairs, Walgreens, Kaiser Permanente and Walmart. And yet,Continue Reading

Drug overdose deaths hit record numbers in 2014

CDC – “From 2000 to 2014 nearly half a million Americans died from drug overdoses. Opioid overdose deaths, including both opioid pain relievers and heroin, hit record levels in 2014, with an alarming 14 percent increase in just one year, according to new data published today in CDC’s Morbidity and Mortality Weekly Report. The mostContinue Reading

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Kaiser – Medicare Penalizes 758 Hospitals For Safety Incidents

Kaiser Health News – “The federal government is penalizing 758 hospitals with higher rates of patient safety incidents, and more than half of those places had also been fined last year, Medicare records released late Wednesday show. Among the hospitals getting punished for the first time are some well-known institutions, including Stanford Health Care inContinue Reading

GAO Reports – Defense Health Care, Littoral Combat Ship, Medicare

Defense Health Care: Research on Hyperbaric Oxygen Therapy to Treat Traumatic Brain Injury and Post-Traumatic Stress Disorder, GAO-16-154: Published: Dec 18, 2015. Publicly Released: Dec 18, 2015. Littoral Combat Ship: Knowledge of Survivability and Lethality Capabilities Needed Prior to Making Major Funding Decisions, GAO-16-201: Published: Dec 18, 2015. Publicly Released: Dec 18, 2015. Medicare: IncreasingContinue Reading