Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
Earlier this year, Marcelin Fortier (hereinafter the “applicant”) sued his insurer in a case. The Superior Court rendered a decision1 whereby it reiterates the principles applicable to the notion of increased risk in insurance. The case also insisted on the importance of the questions asked by insurers at the time an insurance contract is purchased. On 8 January 2015, the applicant’s home was seriously damaged by fire ...
For years, corporate policyholders lacked a clear path to recovery against their insurance companies under the Texas bad faith statute. The reason for this uncertainty was that some courts required a showing of an injury independent from the loss of policy benefits as a means of recovery under the bad faith statute ...
Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment ...
In 2016, West Virginia had the highest death rate in the country from drug overdoses—primarily caused by opioids—at 52.0 for every 100,000 people.[1] The state was on track to exceed that number in 2017.[2] Seeking to enact policies that not only curb but reverse this upward trend, the West Virginia Legislature introduced a number of bills during the 2018 Regular Legislative Session that sought to address this disturbing epidemic. One of these, S.B ...
A New Development on the Subject (Update as of June 15th) Click Here to Read » A flurry of rulings during the last two weeks of May has generated enormous confusion regarding the status of California's two-year-old End of Life Option Act ("EOLOA"), the law that allows a terminally ill adult with a six-month prognosis to obtain aid-in-dying drugs from a physician, subject to numerous safeguards ...
Barry Buchman, Adrian Azer and Greg Van Houten have joined Haynes and Boone, LLP’s Washington, D.C. office in the Insurance Recovery Practice, expanding the group’s presence coast-to-coast. Partner Barry Buchman brings more than 20 years of experience and looks forward to helping the practice flourish in Washington, D.C., and the East Coast ...
Healthcare Hazards Involving Medical Records During Bankruptcy Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and state law framework governing the use and disclosure of medical information. In February 2018, the U.S. Department of Health and Human Services (HHS) announced that it had reached a settlement with the receiver appointed to liquidate the assets of Filefax, Inc ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
Biosimilar developers have been aggressive in filing petitions for inter partesreviews of biologics patents before the Patent Trial and Appeal Board, many ofthem preceding the filing of a marketing application. Such early IPRs are attractiveto biosimilar makers, because they provide a chance to challenge innovator patentsyears before the biosimilar maker files a marketing application with the U.S. Foodand Drug Administration ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
By one account, “the cost of global ransomware attacks will exceed $11.5 billion annually by 2019, up from $5 billion last year and $325 million in 2015” – a 35X increase in just four years.1Relative to other cyber crime, ransomware is an equal opportunity enterprise—striking individuals as well as businesses of all kinds ...
By one account, “the cost of global ransomware attacks will exceed $11.5 billion annually by 2019, up from $5 billion last year and $325 million in 2015” – a 35X increase in just four years.1Relative to other cyber crime, ransomware is an equal opportunity enterprise—striking individuals as well as businesses of all kinds ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018. According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA) ...
Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis. According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...
Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
Legal entities that contract insurance to protect their own assets qualify as consumers within the meaning of the consumer code, says the brazilian Superior Court of Justice (STJ) "[...] the legal entity that takes out insurance seeking to protect its own assets shall be end user of insurance services, thus calling for the application in its favor of the rules provided for in the Consumer Code ...
This year has already been a busy one for seismic activity. In the first weeks of 2018 alone, there have been reports of a 7.9 magnitude quake off the shores of Kodiak, Alaska, a 6.2 magnitude temblor in Japan, and a series of tremors in California. And, few will forget the catastrophic earthquakes that struck Mexico City and the Iraq-Iran border last year ...
