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The British government said it was seeking to hold talks with doctors in its state-funded health service in a last-ditch bid to avert a series of mass walkouts, potentially the first such strikes for four decades…Junior doctors, or doctors in training who represent just over half of all doctors in the National Health Service, said…they would stage a 24-hour stoppage next week, followed by two further 48-hour strikes…It will affect non-emergency care and lead to the cancellations of many operations… Ninety-eight percent of more than 37,000 junior doctors had voted to take part in industrial action, including strikes, in protest against the new employment contract proposed by Health Secretary Jeremy Hunt…The BMA and doctors have criticized the contract, which changes the way they are paid for anti-social hours, saying it does not provide proper safeguards against doctors working dangerously long hours…The government says the new contract is part of measures to ensure patients get the "same quality of care across the week"…"Our absolute priority is patient safety and making sure that the NHS delivers high-quality care 7 days a week – and we know that's what doctors want too, so it is extremely disappointing that the BMA have chosen to take industrial action which helps no-one," Hunt said in a statement.

If there is a surefire way to arouse the concerns of Food and Drug Administration inspectors, try this: take a notebook listing manufacturing problems, place it in plastic bags along with other paperwork, and toss them in a nearby scrap yard where the inspectors can find them...Here’s another approach: leave “unofficial notebooks,” which are used to track manufacturing activities, lying around an office so the inspectors can read how bacteria is present in the water system, but become puzzled when the problem is not cited in official company records...These were just two of several “serious breaches” of good manufacturing practices the FDA cited in a Dec. 23, 2015, warning letter sent to Cadila Healthcare...What else concerned the FDA?

• There were problems with the potency of warfarin made at one plant and Cadila agreed to temporarily suspend production.
• ...nine consumer complaints were lodged by way of pharmacies and distributors over potential product mix-ups.
• Several batches of active pharmaceutical ingredients failed an analysis, but Cadila never explored why this occurred.

Cadila Healthcare Ltd (Zydus Cadila)has received a U.S. Food and Drug Administration warning letter for violating manufacturing standards at two of its production facilities, the latest in a series of Indian companies to face such action....The warning letter cites issues with Cadila's plants in Gujarat, including at the Moraiya facility, which makes up about 60 percent of the company's total sales in the United States, its largest market...Dozens of Indian drug plants have faced warnings and bans in recent years, as the FDA improved inspections of foreign facilities. More than 40 percent of the generic and over the counter medicines available in the United States comes from Indian facilities such as Cadila's Moraiya plant...Cadila Managing Director Pankaj Patel told analysts...the FDA, during an inspection of the Moraiya plant...found deficiencies with the way the company investigated market complaints about a medicine made there...The company is working on a response to the warning letter and will then ask the FDA to reinspect both facilities...It has 15 days to respond to the FDA, as per standard procedures, after which the FDA will decide its response including whether to impose an import ban.

Regulators have logged dozens, even hundreds, of complaints against some health providers for violating federal patient privacy law. Warnings are doled out privately, but sanctions are imposed only rarely. Companies say they take privacy seriously...CVS is among hundreds of health providers nationwide that repeatedly violated the federal patient privacy law known as HIPAA between 2011 and 2014...Other well-known repeat offenders include the U.S. Department of Veterans Affairs, Walgreens, Kaiser Permanente and Walmart...I don’t like the idea of repeat offenders not being called to task for that behavior and I would like to see us doing more in this regard...The number of health information privacy complaints submitted to the Office for Civil Rights within the Department of Health and Human Services has increased dramatically in recent years, in part because of the introduction of an online complaint portal...Using data provided by OCR under the Freedom of Information Act, ProPublica is launching a new tool, HIPAA Helper, which allows users to look up reports of privacy violations by provider for the first time. OCR’s material often referred to the same entities by multiple names. CVS was listed as “CVS,” “Pharmacy, CVS,” “Caremark, CVS,” “CVS Caremark”...We have standardized organizations’ names to make searching easier.

After nearly three years of sparring with a recalcitrant compounder, the Food and Drug Administration has filed a lawsuit asking a federal court to prevent Downing Labs from continuing operations. And the compounder agreed to a consent decree, which requires the company to take various steps before operations can resume...In the lawsuit, the agency cited numerous violations of so-called good manufacturing practices and several issued warnings to the company...about its failure to comply with regulations. Most recently, the Dallas-based compounder, which in 2014 refused to an FDA request to recall some products, failed yet another FDA inspection...the FDA inspectors found unsanitary conditions, according to the lawsuit...tests...found traces of...bacteria which, “if introduced into the body, can cause septic shock, pneumonia, and urinary tract infections,” the lawsuit stated...the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. In fact, the FDA cited the defiant posture taken by Downing as an example of why a new law was needed to allow the agency to bolster its oversight and pursue legal options when compounders refused to upgrade operations.

Healthcare’s “wall-of-shame” for 2015 officially ends tonight at midnight. It’s not really a “wall,” it’s just a website, but it’s the online mechanism for the Office of Civil Rights under Health and Human Services to publish data breaches as reported to them and required by HIPAA. The numbers this year are just staggering...According to OCR, there were 253 healthcare breaches that affected 500 individuals or more with a combined loss of over 112 million records...The Top 10 data breaches alone accounted for just over 111 million records that were lost, stolen or inappropriately disclosed...A recent data breach study estimates that breaches cost the healthcare industry about $5.6 billion annually. As healthcare moves toward connected care, the amount of data exchanged between organizations will only grow. So what does this mean? It means that in 2016, we’re going to see a huge movement towards encryption in hospitals and other healthcare facilities in order to protect EHRs and other vulnerable PHI...Healthcare IT security will continue to fall further and further behind the rest of the industry verticals despite the increase in spending on technology and human resources. The industry is focusing on functionality for patient care and security is an afterthought. Many organizations are also overly dependent on antiquated hardware and software...I wish we could look back on 2015 as the year that healthcare took data security and patient privacy more seriously...In a data-driven world, medical information is just too lucrative and too easy to steal at scale. As long as that’s the case...we should reasonably expect more of the same for 2016.

After Shkreli arrest, 2 drugmakers are upended, 1 seeking bankruptcy protection...KaloBios, the troubled drugmaker taken over by Martin Shkreli last month, is seeking bankruptcy protection less than two weeks after his arrest for securities fraud...It is the second pharmaceutical company with ties to the former hedge fund manager now in turmoil following his indictment on charges unrelated to his involvement with them, though the drugmakers are not lacking for problems of their own...Turing Pharmaceuticals Inc., is cutting jobs and seeking a new CEO after Shkreli resigned the position because of his arrest...Trading in KaloBios shares has been suspended for two weeks and it was notified one week ago that it would be delisted from Nasdaq because of Shkreli's arrest, as well as the arrest of the company's outside counsel...In a Chapter 11 filing...with the U.S. bankruptcy court...the company listed assets and liabilities in the range of $1 million to $10 million...KaloBios' largest creditors include the University of Miami, Ernst & Young and Lonza Sales Ltd.

The government of China continues to refine its legal powers to deal with drug safety issues, according to a release from the country's Supreme Court that says investigations will be streamlined to identify administrative cases that potentially involve major criminal breaches...The new measures are designed to "facilitate coordination between administrative and judicial organs in handling food and drug safety cases," according to a report from the Shanghai Daily...The China Food and Drug Administration and the Ministry of Public Security, the Supreme People's Court, the Supreme People's Procuratorate and the executive office of the food safety commission under the State Council, China's cabinet, said the measures will "streamline" standards and procedures and will include the possibility of suspected drug cases being transferred from administrative bodies such as the CFDA to police...These latest moves are an attempt by Chinese officials to bring trust to the "Made in China" label because most Chinese prefer foreign-made drugs which they believe are higher quality. Several Chinese and Indian companies in recent months have been slammed by regulatory authorities in the United States and Europe over lapses in good manufacturing practices and outright fraud in many cases where test results were falsified.

The federal law that protects health information is violated often and easily, and it's hardly ever enforced...After spending the past year reporting on loopholes and lax enforcement of the Health Insurance Portability and Accountability Act, the federal patient-privacy law known as HIPAA, I’ve come to realize that it’s not just celebrity patients who are at risk. We all are...I’ve talked to hundreds of people who say their medical records were hacked, snooped in, shared or stolen...In each story, a common theme emerged: HIPAA wasn’t working the way we expect. And the agency charged with enforcing it, the HHS office for civil rights, wasn’t taking aggressive action against those who violated the law...We all know HIPAA... It’s what requires us to stand behind a line, away from other customers, at the pharmacy counter or when checking in at the doctor’s office...It is used to scare health-care workers, telling them that if they improperly disclose others’ information, they could pay a steep fine or even go to jail...But in reality, it is a toothless tiger...And even though the civil rights office can impose large fines, it rarely does: It received nearly 18,000 complaints in 2014 but took only six formal actions that year. A recent report from the HHS inspector general said the office wasn’t keeping track of repeat offenders, much less doing anything about them...Making matters worse, HIPAA does not allow patients to sue health providers for damages if they violate the law. So if the federal government doesn’t enforce the law, there are often no consequences for breaking it...Moreover, the government needs to write regulations to implement provisions of a 2009 law that would give patients whose privacy has been violated a share of the money HHS recovers. Finally, the government has yet to submit to Congress a report due in 2010 with recommendations for how to deal with the privacy of health information not covered by HIPAA.

A Clark County child died from the flu, being the first pediatric flu-related death in Clark County for the 2015-16 season, the Southern Nevada Health District said Wednesday...The health district said the child was younger than 5 and that no other information about the death will be released...Clark County reported 26 deaths, 318 hospitalizations and 583 cases of the flu from Oct. 1, 2014, to May 31, 2015.