The Department of Health and Human Services Office for Civil Rights (OCR) has published a Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI). OCR announced the publication of the RFI through a December 12, 2018 press release available here. OCR Director Roger Severino stated that OCR is “looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them ...
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 ...
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 ...
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) ...
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 ...
On 18 January 2019, the Electronic Invoicing (Public Contracts etc.) Amendment (Scotland) Regulations 2019 (the Regulations) were laid before the Scottish Parliament. They come into force on 18 April 2019 for central government authorities and bodies established under the National Health Service (Scotland) Act 1978, and on 18 April 2020 in relation to all other contracting authorities and contracting entities ...
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 ...
To date, the Indonesian government and institutions have largely remained entrenched in an endemic culture of corruption. Despite major victories before the court by the Corruption Eradication Commission (“KPK”) in recent years, crimes of corruption (especially bribery and gratification) remain a major problem at every level of government institution ...
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 ...
“I don’t want a British passport for myself but should I get one for my child?” This is a common immigration-related enquiry, and onemy team and Ihave been asked about by EU nationals repeatedly since the June 2016 referendum vote ...
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” ...
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 ...
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 ...
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 ...
The UK government has announced changes to legislation to reduce the risk of fraud, violence or intimidation faced by company directors as a result of having their residential addresses on the public record. For a number of years, directors have been able to keep their residential address details private by making use of a separate service address, often the company's registered office ...
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”) ...
Now that the holidays are in the rearview and business as usual has begun to pick up where it left off, it’s time for public companies to do a deep download of key securities law updates and business developments of the past year so they are positioned for success in 2019. Below is a review of the 2018 proxy season, along with a summary of new and anticipated changes that may impact reporting and disclosure requirements for the 2019 proxy season ...
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 ...
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”) ...
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 ...
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 ...
The next 60-day regular session of the West Virginia Legislature commences on Wednesday, January 9, 2019. While much of the nation seemed transfixed by the recent electoral changes, the most significant political change in the West Virginia Legislature actually preceded the 2018 general election. Indeed, the House of Delegates elected a new Speaker, Roger Hanshaw (R-Clay), in August 2018 to replace Tim Armstead who resigned to accept an appointment to the Supreme Court of Appeals ...
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 ...
Why is April 1, 2019 Important? April 1, 2019 is the first day U.S. Citizenship and Immigration Services (USCIS) may accept H-1B specialty worker petitions for the next fiscal year, which begins October 1, 2019 ...
