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 ...
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 ...
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 ...
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”) ...
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 ...
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 ...
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 ...
Effective July 29, 2024, the Federal Trade Commission (“FTC”) has issued a final rule that expands the scope of its existing Health Breach Notification Rule (“HBNR”) to include health and wellness applications (“apps”) typically associated with wearable technologies such as smart watches ...
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 ...
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 ...
Customs has changed, with immediate effect, the way in which they deal with goods suspected of infringing brand owners' intellectual property rights. The changes are bad news for brand owners who now have to initiate court proceedings each and every time they wish Customs to seize a consignment of infringing goods ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 Ministry of Health, jointly with the Ministry of Economy, the Ministry of Labor and Social Welfare and the Mexican Institute of Social Security (“IMSS”), recently published specific technical guidelines for companies and work centers to resume activities ...
The Federation's Official Gazette of May 29, 2020, the Ministry of Health, jointly with the Ministry of Economy, the Ministry of Labor and Social Welfare and the Mexican Institute of Social Security (“IMSS”), published specific technical guidelines ...
On June 25, 2020, the U.S. Center for Disease Control and Prevention (CDC) broadened its guidance on who’s at risk of severe illness from COVID-19 due to underlying medical conditions and age. Under the new guidance, the CDC departs from previous guidance stating that only individuals over 65 years of age were at increased risk of COVID-19 due to age, and now states that risk from severe illness from COVID-19 increases with age ...
