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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.

CBI’s Specialty Therapies Forum, the conference that brings together healthcare and pharmaceutical thought leaders to share best practices for managing specialty therapies…an opportunity to discuss not only strategies for managing the cost of specialty therapies, but also to provide the latest information and case studies dedicated to ensuring access and quality care in specialty benefit management. New to the agenda this year is a workshop dedicated to Specialty Pipeline Management.

Dialogue led by key thought leaders:

Avella Specialty Pharmacy | Blue Cross Blue Shield of Massachusetts | Blue Cross and Blue Shield of Minnesota | Blue Cross and Blue Shield of North Carolina | Denver Health Medical Plan | Fairview Specialty Pharmacy | Florida Blue | Gorman Health Group | Horizon Blue Cross Blue Shield New Jersey | Independent Health | NSHOA Cancer Centers in NY | Rutgers RWJ Medical School | Walgreens | Walmart | Widener University

China, already a global powerhouse in high-tech areas…is turning its industrial might to the challenge of making more of its own drugs for a vast and aging population… China is the world's second biggest drugs market behind the United States…Increasing local competition is part of a structural upheaval in China's hospital-dominated prescription drug market. Selling drugs to patients at a hefty mark-up - especially off-patent Western "branded generics" - often accounts for 40-50 percent of Chinese hospitals' revenues. But the authorities are now pushing a policy of zero mark-ups, initially in smaller county hospitals...Pivotal to the transformation of the market is the China Food and Drug Administration…The watchdog has promised to speed up approval of innovative new drugs, which can take 5-7 years…It's probably been taking everyone a little by surprise…As we hit the next decade in the 2020s, I'd be very surprised if there wasn't at least a top 20, if not top 10, global pharma player that was headquartered in China.

Food and Drug Administration should allow the importation of pharmaceutical products from Canada if they meet certain stipulations, Sens. Chuck Grassley and John McCain wrote in a letter to Health and Human Services Secretary Sylvia Burwell… senators call on FDA to “immediately” certify the importation of prescription drugs

• if they are off patent and are no longer marketed by the drug developer,
• if there are “significant and unexplained” price increases,
• if no direct competitor product is currently marketed and the introduction of a new drug will benefit US consumers, or
• if the drug is “produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the United States.”

Drugs could also be imported from countries outside of Canada “with similar regulatory regimes related to drug approvals,”…As far as how FDA could go about allowing such imports, the senators point to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 that allows FDA to permit pharmacists and wholesale retailers to import drugs from Canada.

Mobile medical applications increasingly are being used by patients and consumers. Now healthcare providers are evaluating whether and how to work with their patients in tapping these apps. But they're proceeding cautiously because of the dearth of clinical evidence for many consumer apps, and because some developers may be misleading consumers by overstating their products' capabilities…I think we will be seeing an increase in scrutiny and enforcement by the FDA and the FTC…medical devices treading in the areas of diagnosis and treatment, for those I think we'll see increased enforcement...healthcare providers, a major factor driving that adoption is the shift to value-based payment, which creates a powerful incentive to keep patients healthier and reduce costs by avoiding unnecessary hospitalizations and emergency department use…As with the introduction of any new clinical-care process, there are safety issues…We're going from a situation where we had no data to one where we probably have more data than we need…mobile apps can offer clinical benefits, particularly when used in a structured healthcare program…Healthcare lawyers caution that providers run a variety of legal risks in using mobile apps with patients. “If the patient brings in a bunch of stuff, if you rely on it and it's wrong, it's a problem”…“But if you ignore it and it's right, it's a problem. You're damned if you do and damned if you don't.”

This is an important week for the University of Nevada School of Medicine…officials will submit the school's self-study, an overview of all aspects of their programs…a key document in the effort to earn accreditation…The self-study is a structured review of all aspects of UNLV's proposed program, including what curriculum, resources, faculty and facilities will be needed. The document is an initial step in determining whether the proposed medical school meets standards for structure, function and performance…Dr. Barbara Atkinson, dean of the planned medical school, said the 34-page executive summary of the self-study will be available to the public online after her team submits the document to the Liaison Committee on Medical Education (sponsored by the Assn of Amer. Med. Colleges and the Council on Med. Education of the Amer. Med. Assn) UNLV and Roseman University of Health Sciences both are seeking accreditation for planned medical schools. Each would have the capacity to teach 60 students each year, starting in 2017. Roseman officials submitted their self-study over the summer…

Despite the howling from political candidates trying to make the top drug-makers their whipping boy in populist campaign efforts, the need and demand for pharmaceuticals will only continue. This is especially the case when you consider that we now live in a world with an aging population that is going to be popping more and more doctor-prescribed pills…While pricing and cost concerns won’t go away completely until the election cycle winds down, now may be an ideal time to add the top yielding stocks to portfolios for 2016…The companies we found have long histories of paying and raising their dividends, and make good sense for conservative growth and income portfolios.

• Abbott Lab
• Eli Lilly
• Merck & Co.
• Pfizer

The high cost of R&D is used to explain why drugs giants merge, and why they must charge high prices. The reality is somewhat different…Pfizer’s boss, put it, the merger will create “a leading global pharmaceutical company with the strength to research, discover and deliver more medicines and therapies to more people around the world.”…the common suggestion that size is needed to create a research-driven powerhouse does not stack up…the industry is…moving away from a model in which giant firms throw huge sums at in-house research in a quest for ground-breaking new treatments… rather than spending heavily in many different areas of cutting-edge research, the largest firms are increasingly buying in drugs that are already in the course of development. In some cases they do so by buying other established firms…the drugs giants are buying smaller, younger biotechnology firms which focus on a single-treatment approach…in the past 20 years those drug companies that consistently did well in various therapeutic areas were earning more than 70% of their sales from products developed elsewhere.

Swiss drugmaker Roche Holding has dropped out of a high-profile project to develop an antibiotic for treating "superbug" infections…"Roche has decided to discontinue its involvement in the clinical development of the investigational antibiotic RG7929/POL7080 for the treatment of patients with severe Pseudomonas aeruginosa infections and will return the asset to Polyphor,"…Roche spokesman said that antimicrobial resistance remained a major threat to public health and Roche would continues to focus on this unmet medical need as part of its infectious disease research and development strategy.

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...