In order to allow the importation of medicines and other products for human health,during the State of Emergency, the National Directorate of Pharmacy and Drugs (DNFYD) of the Ministry of Health, has issued Resolution 280 of April 6, 2020 published in Official Gazette No ...
The identification of the food and drink sector as key in the response to the COVID-19 (C19) crisis seems obvious and unquestionable. Scratch the surface though and questions emerge, perhaps unsurprisingly because of the haste with which the emergency legislation was passed. The starting point recognised in the Coronavirus Bill was that the food supply chain involved not just producers but also intermediaries ...
COVID-19 came upon us all like a tsunami, leveling life as we knew it and causing an entirely new paradigm of behavior to be necessary. No segment of the population was hit harder than seniors, both in our communities and in senior care facilities. Long-term care facilities were on the frontlines of the battle, being one of the first industries to be required to wholly alter traditional behaviors to try to stop the inevitable spread of this deadly virus ...
Chapter 8: Technical Barriers to Trade This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices ...
Temporary flexibility of the terms of adjustment of guarantees and the term to carry out audits to the Reliability Charge was defined. The Energy and Gas Regulation Commission, seeking to guarantee the proper provision of electric power service, decrees that the value of the guarantee in Article 31 of CREG Resolution 061 of 2007 will not be adjusted in the scenario presented in paragraph 2, numeral 3: 3 ...
A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...
The Health Insurance Portability and Accountability Act (“HIPAA”) contains minimum security standards that Covered Entities and Business Associates must employ to safeguard protected health information (“PHI”). As part of HIPAA’s security standards, Business Associates are obligated to report all security incidents to the Covered Entity ...
The Eighth Circuit Court of Appeals held that a D&O liability insurer could not rely on ambiguous endorsements as a basis to deny coverage for claims brought by investors against its insured company and its CEO. Reversing the Eastern District of Missouri, the appellate court in Verto Medical Solutions LLC et al. v. Allied World Specialty Insurance Co., No. 19-3511 (8th Cir ...
According to press reports, most Germans are willing to accept limitations on the extent of the protection of their personal data vis-à-vis public authorities and agencies in order to tackle the coronavirus crisis. However, that alone is not an adequate justification for measures that employers may take during a coronavirus pandemic to prevent an outbreak in their company ...
In September 2020, a team of MIT researchers published a paper in the IEEE Open Journal of Engineering in Medicine and Biology, testing the hypothesis that coronavirus carriers—even asymptomatic ones—could be accurately detected using artificial intelligence (AI) based on only a phone recording of a forced cough.If this hypothesis is correct, the COVID-19 test can be accessible to people worldwide ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. On October 6, 2023, the DEA jointly with the U.S. Department of Health and Human Services (HHS) announced a Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (the “Second Extension”) ...
About a year ago, on Nov. 20, 2020, the Department of Health and Human Services Office of Inspector General and the Centers for Medicare and Medicaid Services (CMS) issued two final rules implementing sweeping changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute regulations. For the most part, those new rules went into effect on Jan. 19, 2021 ...
On December 3, the U.S. Patent and Trademark Office (“USPTO”) will make a major change to how it processes trademark applications, which is anticipated to affect filing strategies, work flow, and even budgets. Brand owners in the U.S. might be wondering what they need to know about the Trademark Modernization Act’s (“TMA”) shortened office action response deadline ...
The Plurinational State of Bolivia, within the framework of its governmental powers and in accordance with the Declaration of Sanitary Emergency and Quarantine established in recent days, has determined to strengthen the latest measures. The government has conviniently declared that the total quarantine, extends until April 30, 2020, maintaining the suspension of public and private activities ...
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...
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 ...
Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry ...
Recently, modifications announced by the Department of Health and Human Services (“HHS”) to 42 C.F.R. Part 2 (“Part 2”) rules governing Confidentiality of Substance Use Disorder (“SUD”) Patient Records went into effect. This is a major rule change for Part 2 providers and the enhanced penalties and enforcement measures make compliance with the new rules essential for any Part 2 provider ...
The U.S. Department of Justice recently announced an enforcement initiative targeting the pharmaceutical industry for investigations and prosecutions under the Foreign Corrupt Practices Act (FCPA). The FCPA prohibits improper payments to foreign government officials for the purpose of obtaining or retaining business and mandates that companies that issue securities take affirmative measures to prevent such payments ...
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 ...
