In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
On April 10, 2015, the Texas Medical Board (“TMB”) voted in favor of adopting amendments to the rules governing telemedicine. The revised rules, which will significantly limit the ability to treat patients via telephone and video consultation, take effect June 3, 2015. TMB took its first steps to curb telemedicine in January 2015 by passing an emergency measure that prohibited prescribing drugs without an initial in-person visit ...
In a judgment handed down on January 30, 2015, the Court of Québec held that the failure to respect the prescribed time limits or the violation of a patient’s fundamental rights and freedoms does not lead to the automatic exclusion of a psychiatric examination report concluding that the patient should be confined ...
At first glance, "net neutrality" may seem a natural principle for the internet environment. This expression, however, gives rise to sometimes divergent interests and some concerns. As a general concept, net neutrality means an open Internet, through which consumers would be able to make their own choices about the content they wish to access and share, as well as the services and applications they want to use ...
When Congress passed the Medicare Access and CHIP Reauthorization Act of 2015, the elimination of the Sustainable Growth Rate—the so-called “Doc Fix”—received most of the attention. The fact that Congress had officially waded into the quagmire of health information technology interoperability, however, went largely unnoticed ...
On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...
In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...
In this age of social networks, the dividing line between private life and public life seems more and more blurred. The same is true of the boundary between individuals' personal and professional lives. Indeed, headlines in the past few weeks remind us that the personal and professional aspects of an individual's life can sometimes become confused, at great cost to the individual ...
Earlier this year, the UK government launched 'Tech Nation'; an interactive data project that shows the growth of digital businesses within specific areas/regions across the UK. The report is the first of its kind and ranked Belfast as the second highest region in the UK in terms of the highest average company turnover in this sector, with Greater Manchester securing the top spot and Sheffield, Inner London and South Wales coming third, fourth and fifth respectively ...
Writer, Margaret Rouse, describes a social media policy as “a corporate code of conduct that provides guidelines for employees who post content on the internet, either as part of their job or as a private person”. Underestimating the significance of a sound social media policy may lead to dire consequences for an organisation ...
The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
In this article, we provide a brief overview of the most important new rules applicable to Hungarian data protection laws after 1 October 2015. BCRs accepted after 1 October 2015 Binding corporate rules (BCR) have so far not been recognized by Hungarian law and, thus, could not be used whenever personal data were transferred to a non-EEA country ...
On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago ...
In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...
On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products ...
It’s no surprise that the National Cybersecurity Center of Excellence (NCCOE) has extended the public comment period for one of its newest guides, “Securing Electronic Health Records on Mobile Devices ...
The Philippine section of The International Comparative Legal Guide to: Patents 2016 was contributed by SyCipLaw partners Enrique T. Manuel and Vida M. Panganiban-Alindogan. The chapter includes patent enforcement, patent amendment, licensing, patent term extension, patent prosecution and opposition, border control measures, antitrust law and inequitable conduct and current developments in relation to patents ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
Many healthcare boards believe that they have satisfied the 501(r) community health needs assessment (CHNA) requirements by completing their organization’s CHNA report and adopting an implementation strategy. After doing that, the board may feel ready to focus on other pressing issues until the next three-year CHNA deadline ...
The Finnish Criminal Code has been recently amended to combat cybercrime more effectively. The Criminal Code now takes a tougher stance against cybercrime by amending certain provisions, introducing completely new provisions and more severe penalties. The amendments entered into force 4 September 2015. From now on, cybercrime offences, such as illegal data interference and identity theft, can be found under their own titles in the Criminal Code ...
Although many of us still wonder at a drone cruising the sky, it has become relatively common to see these devices around. Drones are used for commercial, industrial, marketing and informational purposes, and also for pure fun and enjoyment. Drones, technically referred to as Unmanned Aerial Vehicles (UAV), are now part of our lives. As many other aspects of day-to-day life, there is a regulation in Guatemala that applies to drones, though it is scarcely known by the general public ...
Over the past year, the Tribunal administratif du Québec (TAQ) has issued several rulings dealing with oversight of the medical practice of professionals working in health and social services institutions. Several of these rulings will be of interest to institutions since they set out principles that tend to confirm the existence of a form of management rights over physicians, despite the lack of the traditional relationship of subordination between such institutions and their physicians ...
After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...
