Firm: All
Practice Industry: Healthcare & Pharmaceuticals, Insurance, Technology
Region: All
Country/ State: All
Tag: All
Dinsmore & Shohl LLP | November 2018

On Nov. 19, 2018, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce issued an Advance Notice of Proposed Rulemaking[1] requesting public comment on criteria for identifying emerging technologies essential to U.S. national security that would be subject to increased export controls ...

Dykema | November 2018

Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S ...

Heuking | November 2018

When auditing annual financial statements, auditors are required to draw attention to risks that potentially threaten the company. Such risks can result for example from failure to implement the EU General Data Protection Regulation (GDPR) that has been in force since May 25, 2018. Given the substantial fines envisaged in the GDPR, these risks can result in high provisions, in the worst case in refusal on the part of the auditor to issue an unqualified audit opinion ...

Dinsmore & Shohl LLP | November 2018

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...

Dinsmore & Shohl LLP | November 2018

In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...

Dinsmore & Shohl LLP | November 2018

Recently, the Ohio Department of Medicaid (ODM) proposed the adoption of Ohio Administrative Code 5160-1-32.1 (the Proposed 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 ...

Simonsen Vogt Wiig AS | November 2018

The value of the car is no longer merely associated with the car body, its engine or other material parts. Substantial value is found in the knowledge that controls the car – knowledge that does not only steer the car, but which may form the basis for maintenance and repairs planning, computing insurance premiums or indicating who is liable in the case of damage ...

Dinsmore & Shohl LLP | November 2018

Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule) ...

A&L Goodbody LLP | November 2018

Earlier this week, the UK Cryptoassets Taskforce published its Final Report on cryptoassets and distributed ledger technology (DLT). The Taskforce – which includes representatives from HM Treasury, the UK Financial Conduct Authority (FCA) and the Bank of England – was established in March 2018 to analyse and assess the risks and potential benefits of cryptoassets and DLT and “set out the path forward with respect to regulation [of these areas] in the UK” ...

Deacons | October 2018

In Haberdashers’ Aske’s Federation Trust Ltd v Lakehouse Contracts Ltd [2018] EWHC 558 (TCC), England’s Technology and Construction Court had to decide on the extent of coverage (or inclusion) of a project insurance policy for a construction project and how that coverage was affected by a sub-contractor having its own insurance cover ...

Dinsmore & Shohl LLP | October 2018

In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...

MinterEllison | October 2018

Information is critical to the conduct of health and medical research. Much of the time the information relates to individuals. Higher education institutions regularly collect, use, disclose and hold information, including health information, for research purposes ...

Blockchain is a distributed ledger of data entries. The entries are processed and managed by a series of different computers, or ‘nodes’, which can be running on different servers. Every computer connected to the system keeps a copy of this ledger, meaning that different parties can view and manage the same information in real time. It also makes it exceptionally safe and secure. The energy sector has been relatively slow to adopt blockchain technology ...

Alta QIL+4 ABOGADOS | October 2018

The role of the Millennial lawyers and the recent incorporation of Artificial Intelligence (“AI”) in law firms are current trending topics. As a 27-year old associate of a law firm based in Guatemala City, every time I read about AI and that global law firms are incorporating AI to their practice, I ask myself, will I be replaced by it (or IT) ...

Afridi & Angell | October 2018

The Abu Dhabi Global Market (the ADGM) recently announced the launch of a commercial license specifically catered towards tech start-ups that allows entrepreneurs to obtain an operational license in the ADGM and access to a Professional Services Support Program aimed at allowing entrepreneurs entry to a community of businesses, financial services and professional advisors ...

Hunton Andrews Kurth LLP | October 2018

Brick and mortar retailers are rapidly diversifying checkout and payment methods to combat the erosion of sales to online channels and provide an improved shopping experience for consumers. From self-checkout kiosks, to store-specific mobile applications for payment, scan-as-you-go devices, and even ‘just walk out’ models, retailers are reinventing consumer’s notions of the traditional checkout line by going cashierless ...

Heuking | October 2018

It is now more than four months since the EU General Data Protection Regulation (GDPR) became law in all member states of the European Union. Time for an initial and brief interim assessment, and to outline the data protection challenges currently facing companies. Feared spamigation has not materialized To date, the widely feared mass sending of cease-and-desist letters (spamigation) has largely failed to materialize ...

FISCHER (FBC & Co.) | October 2018

At the beginning of September, the Israeli Innovation Authority, a division of the Israeli Ministry of Economy and Industry and the successor to the Office of Chief Scientist “IIA”, issued new rules “New Rules”. The “New Rules” regarded the licensing of know-how developed and obtained by Israeli companies that received grants from the IIA “Funded Companies”, to multinational corporations ...

MinterEllison | October 2018

Following a short period of public consultation, the Telecommunications and Other Amendments (Assistance and Access) Bill 2018 (Cth) (Bill) has been introduced into Parliament. Despite the extensive public concerns raised with the Exposure Draft version, only a small number of amendments have been made to the Bill. Following extensive submissions and much debate, the 'decryption Bill' has now been introduced into Parliament ...

Dinsmore & Shohl LLP | October 2018

The Ohio Supreme Court yesterday reversed the decision of a lower court of appeals and held that a general contractor is not entitled to insurance coverage for property damage arising out of its subcontractor’s faulty work, even when the general contractor purchased a CGL insurance policy with a rider pertaining to coverage related to a subcontractor’s faulty work ...

Dinsmore & Shohl LLP | October 2018

The Ohio Supreme Court yesterday reversed the decision of a lower court of appeals and held that a general contractor is not entitled to insurance coverage for property damage arising out of its subcontractor’s faulty work, even when the general contractor purchased a CGL insurance policy with a rider pertaining to coverage related to a subcontractor’s faulty work ...

Heuking | October 2018

Many companies are currently facing challenges in relation to the GDPR compliance of their video surveillance. Main issues in this respect are questions related to transparency requirements and information notices, the need for a data protection impact assessment as well as questions concerning retention requirements and retention periods. The German Federal Labor Court (BAG) has recently commented on the admissible storage duration of lawful video recordings ...

Haynes and Boone, LLP | October 2018

A new round of U.S. tariffs on $200 billion in Chinese imports became effective on September 24, 2018.1The 10 percent tax on Chinese consumer products is only the latest escalation in an ever-widening trade war between the United States and its global trading partners. While it appears that, subject to Congressional approval, trade disputes between the U.S ...

Haynes and Boone, LLP | October 2018

A new round of U.S. tariffs on $200 billion in Chinese imports became effective on September 24, 2018.1 The 10 percent tax on Chinese consumer products is only the latest escalation in an ever-widening trade war between the United States and its global trading partners. While it appears that, subject to Congressional approval, trade disputes between the U.S ...

Dinsmore & Shohl LLP | October 2018

In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...

dots