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Only half of small urban hospitals have two-factor authentication capability…Fewer than half of U.S. hospitals support an infrastructure capable of two-factor authentication, The Office of the National Coordinator for Health IT reported…while 35 percent of critical access hospitals and 40 percent of small rural hospitals report the lowest levels of capability…Two-factor authentication requires users to give at least one other form of identification beyond username and password to get access to electronically protected information, such as a PIN and fingerprint or voice recognition…The process is a low-cost, effective way to meet HIPAA standards, but not enough hospitals have implemented it into their cybersecurity plans…cybersecurity experts assert reported levels of adoption are still drastically low, given the steady rise in healthcare data breaches and the increase in hackers targeting the healthcare industry…Some states are above the bar on establishing two-factor authentication. Ohio raked at the top with 93 percent adoption..Vermont, with 83 percent…Delaware, with 81 percent…On the other hand, Montana, with 19 percent, North Dakota, with 23 percent, and Maine, with 26 percent, saw the lowest percentages…

Before…Theranos suspended use of its finger-prick blood draws in September because of Food and Drug Administration concerns, the company tangled with Arizona lab regulators over testing instruments and lab practices…Theranos, which operates retail locations inside 40 Walgreens stores across metro Phoenix, did not always meet lab regulations before taking corrective steps, according to inspection reports…After an April 2 survey of the company's Scottsdale lab, Arizona Department of Health Services inspectors noted four "deficiencies" at the lab...The state inspectors conducted the survey on behalf of the federal Centers for Medicare and Medicaid Services, which regulates laboratory testing…The four issues concerned proficiency testing, validation of instruments used to analyze blood samples, humidity levels outside of acceptable ranges for some lab instruments and how blood-sample collections were dated…In September, state lab inspectors said that Theranos did not meet proficiency testing standards for certain substances, including toxicology and four other regulated substances.

…the Orphan Drug Act was passed to give drug makers incentives to create medicines for rare diseases, which are defined as maladies that affect fewer than 200,000 people. The incentives include tax credits and seven years of marketing exclusivity. Since then, more than 400 orphan drugs have been approved by the Food and Drug Administration. Last year, though, 41 percent of all FDA approvals were for orphan drugs. And sales of orphan medicines, which carry high price tags, are forecast this year to total $107 billion…team of researchers argues that drug makers are exploiting loopholes that allow them to widen the market for such drugs and distorting the original purpose of the law. We spoke with Martin Makary, a cancer surgeon and professor of health policy at Johns Hopkins School of Medicine…

Executives with Arizona's nonprofit health insurance co-op said Tuesday that they have failed to come up with additional financial backing and the insurer plans to shut down all operations Dec. 31…The announcement by Meritus Health Partners means 59,000 Arizonans it now covers need to find a new insurer by Dec. 15…The decision comes nearly a month after the state Department of Insurance suspended its right to sell new policies or renew current ones and placed it under formal supervision… The nonprofit was one of 23 co-ops created under the Affordable Care Act to provide competition to for-profit insurers, but many have struggled and more than half have now failed or will close by the end of the year.

New numbers show Nevadans have been slow to jump into the state's health insurance exchange…Department of Health and Human Services reported Wednesday that 23,248 Nevadans bought coverage through Nevada Health Link in the first month of open enrollment, from Nov. 1 through Saturday…That's roughly half of the 40,285 residents who bought a plan through the exchange in the first month of sign-ups a year ago…Federal officials said enrollment should pick up as the Dec. 15 deadline nears to buy a plan with a Jan. 1 start date...Consumers without coverage in place by then face a federal tax for going without health insurance.

Lahey Hospital and Medical Center has agreed to pay $850,000 in a settlement with HHS' Office for Civil Rights to resolve alleged privacy and security violations stemming from the theft of a laptop computer with unencrypted patient records…health system also entered into a corrective action plan to address other privacy and security issues raised during the breach investigation. Lahey “impermissibly disclosed” electronic medical records of 599 individuals “for a purpose not permitted by the privacy rule” under the Health Insurance Portability and Accountability Act…Lahey had failed to meet a number of other HIPAA requirements, including not conducting “an accurate and thorough” security risk analysis, failing to assign “a unique username for identifying and tracking user identity” on the stolen computer and failing to “implement a mechanism to record and examine activity” on the computer.

Bergen is the last stop on a global drug route that gives it one of the worst heroin problems in Europe…Now with a change in local government here and in the capital, Oslo, there is an appetite to use radical policies to curb the alarming number of Norwegians who die from heroin overdoses each year. Alongside traditional replacement therapies, such as methadone, the new left-wing local leaders want to use a medical form of injectable heroin [diamorphine] to treat the most at-risk users…The official goal is to wean them off the drug entirely, but even the most ardent supporters admit the most achievable target is to bring them within a safer environment, while helping to tackle the crime associated with heavy drug use…Norway has the worst heroin mortality rate in Western Europe...

Foreign pharmaceutical firms are looking for the bright side in Russia’s import substitution plan for the drug manufacturing sector…When…Prime Minister Dmitry Medvedev tasked the government with creating a program of import substitution in the field of pharmaceutical production, foreign companies were worried. Although Russia’s pharmaceutical market…a fraction of that of the U.S…its loss would have been a blow to Western drug companies at a time of global economic crisis...the policy may not have such serious implications…the import substitution policies will only affect sales to public health organizations, primarily state-run hospitals and pharmacies. Private health clinics and pharmacies are still able to import foreign drugs without restrictions…60 percent of the drugs on the List of Vital and Essential Medicines approved by Russian government bodies for use in public institutions are produced domestically. Under the new policy, this share should increase to 90 percent by 2018.

President Obama has signed a law that resets approval dates for some medicines that contain controlled substances. The goal is to streamline the process used by the Drug Enforcement Agency to place prescription drugs that are controlled substances on a list of medicines for which distribution is restricted…the new law ensures that a company offering such medications will not effectively lose time from a five-year period under which it can exclusively market the drugs…Drug makers have griped they are often at a competitive disadvantage, since controlled substances must first be placed on the DEA list before they can reach pharmacies. Companies have complained the process is often lengthy and hampers their ability to take advantage of a five-year marketing exclusivity period following Food and Drug Administration approval during which generic competition is delayed…the Improving Regulatory Transparency for New Medical Therapies Act, would require the DEA to list a drug within 90 days after receiving notice from the FDA...

Food and Drug Administration says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety…The agency is also considering a recent MDEpiNet study…found women who received Essure had a "more than 10-fold higher risk of undergoing reoperation," when compared to women who had laparoscopic sterilization…Essure is a permanent birth control device…marketed by Bayer…Essure was first approved...in 2002 under FDA's premarket approval process…In recent years Essure has been surrounded by controversy as patients and activists have claimed the device has caused serious and debilitating side effects… Others have claimed the device is not as effective as it claims…in November, Representative Mike Fitzpatrick introduced a bill titled the E-Free Act directing FDA to pull Essure's PMA within 60 days of the bill's passage. So far the bill has four co-sponsors, including Reps. Marsha Blackburn, Christopher Smith and Lou Barletta.