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Karanovic & Partners | January 2019

The US tech giant, Google is fined EUR 50 million by France's data protection regulator, CNIL, for failing to comply with its General Data Protection Regulation (GDPR) obligations. This is the biggest GDPR fine yet to be issued by a European regulator and the first time that one of the tech giants has been found in breach with the new regulations that came into force in May 2017 ...

Hanson Bridgett LLP | January 2019

On January 28, 2019, the California Department of Social Services issued a letter informing all licensed Residential Care Facilities for the Elderly that Title 22, Section 87224 of the California Code of Regulations has been revised. Section 87224 previously provided for a 30-day eviction notice to residents upon the change of use of a facility. This notice period was inconsistent with the applicable statute, Health and Safety Code Section 1569.682(a)(2) ...

Dinsmore & Shohl LLP | January 2019

Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic.  EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...

Heuking | January 2019

The use of the Internet without the use of search engines, which list links to Internet pages after keywords have been entered, is almost unthinkable. In the context of the search results, however, websites may appear that contain personal data and thus fall within the scope of the GDPR ...

Dinsmore & Shohl LLP | January 2019

On January 21, 2019, Google was fined nearly $57 million (approximately 50 million euros) by France’s Data Protection Authority, CNIL, for an alleged violation of the General Data Protection Regulation (GDPR).[1] CNIL found Google violated the GDPR based on a lack of transparency, inadequate information, and lack of valid consent regarding ad personalization. This fine is the largest imposed under the GDPR since it went into effect in May 2018 and the first to be imposed on a U.S ...

Heuking | January 2019

The Brexit Withdrawal Agreement negotiated between the European Union and the United Kingdom envisaged that during the United Kingdom's transitional period data protection legislation would have been treated in the same way as with the countries of the European Economic Area. This would have allowed a transfer of personal data from the European Union to the United Kingdom without additional measures to ensure adequate levels of data protection ...

Veirano Advogados | January 2019

The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication ...

In a landmark decision, the European Union Intellectual Property Office (‘EUIPO’) has ruled that McDonald’s, one of the world’s largest fast food chains, will lose its EU trade mark for “Big Mac” ...

Dinsmore & Shohl LLP | January 2019

The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...

Heuking | January 2019

The Court of Justice of the European Union (ECJ) must currently clarify whether and how website operators can legally integrate the so-called "Like" button of Facebook on their website (Case C-40/17). A German online retailer had integrated the "Facebook Like" button into their online shop. Due to the functionality of the "Facebook Like" button, personal information was transmitted to Facebook Ireland each time the website was visited, including the IP address ...

Haynes and Boone, LLP | January 2019

A new rule promulgated by the U.S. Environmental Protection Agency (“EPA”) governing the disposal of coal combustion residuals, also known as CCR or coal ash, raises the risk for civil claims and the need for insurance to cover them.1  The rule, which takes effect Aug. 29, 2018, revises regulations issued in 2015 and has the stated intent of providing utilities and states “more flexibility in how CCR is managed ...

ALRUD Law Firm | January 2019

During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines (“Guideline”) ...

Dykema | January 2019

The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality ...

Dykema | January 2019

A physician certification for Medicare coverage for ambulance services is not the final word. An ambulance service also must demonstrate the beneficiary’s condition and establish medical necessity when transporting the Medicare beneficiary ...

Dykema | January 2019

Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...

On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1]  The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...

Dinsmore & Shohl LLP | January 2019

The U.S. Court of Appeals for the Sixth Circuit, in Massachusetts Bay Insurance Company v. Christian Funeral Directors, Inc., No. 18-5267 (6th Cir. Dec. 26, 2018), recently upheld a district court’s declination of jurisdiction over an insurer’s declaratory judgment action on coverage ...

Dinsmore & Shohl LLP | January 2019

The U.S. Court of Appeals for the Sixth Circuit, in Massachusetts Bay Insurance Company v. Christian Funeral Directors, Inc., No. 18-5267 (6th Cir. Dec. 26, 2018), recently upheld a district court’s declination of jurisdiction over an insurer’s declaratory judgment action on coverage ...

Dinsmore & Shohl LLP | January 2019

In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...

Dinsmore & Shohl LLP | January 2019

Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...

Dykema | January 2019

On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...

Dykema | January 2019

The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...

Heuking | January 2019

Under its Article 88(1), the GDPR allows Member States to draw up their own rules for the area of employee data protection. Germany has taken advantage of this option with Section 26 of the Federal Data Protection Act (BDSG). The first sentence of Section 26(1) already applies while the decision to establish an employment relationship is made and hence it needs to be taken into account early in the application process ...

Simonsen Vogt Wiig AS | January 2019

To protect and stimulate creators to increase innovation and encourage entrepreneurship, Norwegian authorities are changing the law. In 2018 we received several proposals towards strengthening the rights of those who create new ideas or build their business on intellectual property. Looking back at 2018, we see a year in which the Norwegian intellectual property (IP) legislation has been in movement. Technology is developing fast, and so must the law protecting technology ...

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