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Diagnostic Tests Healthcare

McAfee & Taft

New ADA regulations issued on the accessibility of medical diagnostic equipment used by public entities

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On August 9, 2024, the U.S. Department of Justice published a final rule implementing new ADA requirements for accessible medical diagnostic equipment (MDE) used in hospitals, emergency departments, physicians’ offices,...more

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

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As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Nelson Hardiman, LLP

The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges

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Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more

Stikeman Elliott LLP

Ontario Issues Call for Applications for Community Surgical and Diagnostic Centers

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Ontario has (finally!) made the call to community surgical and diagnostic centers for applications for new licences under the Integrated Community Health Services Centres Act, 2023 (the Act) to provide MRI and CT services. ...more

Manatt, Phelps & Phillips, LLP

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the...more

Hendershot Cowart P.C.

Do Cosmetic Injections Involve The Practice Of Medicine?

Cosmetic injections, such as Botox and dermal fillers, and weight-loss injections, such as Wegovy® and Ozempic®, are popular offerings at med spas, weight-loss clinics, and dermatology practices. But are they considered the...more

MoFo Life Sciences

At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, And Distribution Agreements

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The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

Napoli Shkolnik

Diagnostic Errors Claim Nearly 800,000 American Lives Per Year, Study Finds

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A new study shows that approximately 371,000 people die and 424,000 sustain permanent disabilities due to diagnostic error, including brain damage, blindness, loss of limbs or organs or metastasized cancer....more

McDonnell Boehnen Hulbert & Berghoff LLP

International Trade Commission Issues Report of COVID-19 IP Waiver

It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more

Manatt, Phelps & Phillips, LLP

Leveraging Medicaid to Support Children and Youth Living With Complex Behavioral Health Needs

Editor’s Note: In a new report prepared for The Commonwealth Fund, Manatt Health and its co-authors provide an actionable framework and strategies for how state-level policymakers can use Medicaid and the Children’s Health...more

Hogan Lovells

FDA pilots oncology companion diagnostic test/device program as LDT rulemaking nears

Hogan Lovells on

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more

Epstein Becker & Green

Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care

Epstein Becker & Green on

A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection...more

Stinson LLP

Considerations for Group Health Plans as COVID-19 Emergency Declarations End

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Part I: COVID-19 Diagnostic Testing Coverage - On January 30, 2023, the Biden Administration announced that it intends for the National Emergency (NE) relating to the COVID-19 pandemic to end on May 11, 2023....more

Stinson - Benefits Notes Blog

Preparing for the End of the COVID-19 Emergency Declarations: Part I. Considerations for COVID-19 Diagnostic Testing Coverage

On January 30, 2023, the Biden Administration announced that it intends for the National Emergency (“NE”) relating to the COVID-19 pandemic to end on May 11, 2023. Shortly after, the Secretary of the Department of Health and...more

Knobbe Martens

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

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The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

Epstein Becker & Green

Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care

When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it. What unique challenges do direct access tests (DATs) pose when it comes to...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical

Maynard Nexsen on

Joining hosts Matthew and Heather again is Mako Medical’s COO and co-founder, Josh Arant. After the medical diagnostic lab served a major role during the height of the pandemic, Mako is currently addressing the surges in flu,...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - December 2022 #2

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CYBERSECURITY - Nineteen States Have Banned TikTok on Government-Issued Devices - Governors of numerous states have issued Executive Orders in the past several weeks banning TikTok from government-issued devices and...more

Console and Associates, P.C.

A Needlestick Can Cause CRPS: What Patients Need to Know About Routine Blood Draws, Complex Regional Pain Syndrome, and Options...

Attorneys across the nation have noticed an increase in the number of potential plaintiffs coming forward with a painful condition called complex regional pain syndrome (CRPS) that they believe resulted from needlestick...more

Fox Rothschild LLP

US Launches Nationwide Coordinated Law Enforcement Action to Combat Health Care-Related COVID-19 Fraud

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As part of its ongoing effort to crack down on health care-related COVID-19 fraud, the U.S. Justice Department has launched a nationwide coordinated law enforcement action that recently led to criminal charges against 21...more

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

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ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Knobbe Martens

Researchers Develop Blood Clot Test Based on Single Drop of Blood

Knobbe Martens on

The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone....more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Foley & Lardner LLP

Personalized Medicine Coalition Releases Spring 2020 Newsletter Amid the Coronavirus

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...The Personalized Medicine Coalition (“PMC”) recently published its 2020 Spring Newsletter that examines the landscape and outlook for personalized medicine as COVID-19 prompts new discussions about the effect of COVID-19...more

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