News & Analysis as of

Healthcare Research and Development

Health Care Compliance Association (HCCA)

Missing COI Program, Fabricated Outreach, Job, Health Records: The Many Types of Falsehoods

Report on Research Compliance 21, no. 9 (September, 2024) - How many types of falsehoods might sully applications for research funds and the studies they support? Unfortunately, the most recent semiannual report to...more

McDermott Will & Emery

Key Takeaways | Clinical Research Technology (ClinTech)

McDermott Will & Emery on

During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more

Gardner Law

FDA Highlights the Promise of AI in Healthcare

Gardner Law on

On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more

Akin Gump Strauss Hauer & Feld LLP

Senate AI Working Group Releases Long-Anticipated Roadmap for AI Policy

On May 15, 2024, the Senate AI Working Group—Senate Majority Leader Chuck Schumer (D-NY) and Sens. Mike Rounds (R-SD), Todd Young (R-IN), and Martin Heinrich (D-NM)—issued their long-anticipated Roadmap for Artificial...more

Mintz - Antitrust Viewpoints

Federal Agencies Take Sweeping Action on AI in Accordance with AI EO — AI: The Washington Report (Part 2 of 2)

President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Manatt, Phelps & Phillips, LLP

Biden Administration Doubles Down on Investment in Women’s Health

On March 18, the Biden Administration announced that it is doubling down on its commitment—previously announced during President Biden’s State of the Union address—to transform women’s health research and improve the lives of...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Cozen O'Connor

Broad Street Brief: Council Investigates City’s Carbon Neutrality Efforts

Cozen O'Connor on

A Preview of Mayor Parker’s First Budget Proposal Mayor Cherelle Parker will present her first budget plan next week, which is expected to focus largely on her campaign promises to make Philadelphia safer, cleaner, and...more

Manatt, Phelps & Phillips, LLP

February 29, 2024: The “Rarest Day of the Year”

Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare...more

Robinson+Cole Data Privacy + Security Insider

HHS Addresses the Growing Influence of Artificial Intelligence in Health Care

Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform­ its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

Mintz - ML Strategies on

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

Seyfarth Shaw LLP on

On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: December 2023

Report on Research Compliance 20, no. 12  (December 2023) Although the National Science Foundation (NSF) allowed more than half the costs questioned by auditors for its Office of Inspector General (OIG), the California...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

The Real Challenges That Stop Hospitals From Integrating Clinical Trials Into Clinical Care

Editor’s Note: In the autumn issue of the Clinical Research as a Care Option (CRAACO) newsletter, an interview with Manatt Health’s Donna O’Brien gives pharma readers insight into how hospitals view trials, some of the...more

Health Care Compliance Association (HCCA)

What do burglars do on WFH Day?

Perhaps you haven’t pondered this question. On work-from-home days, do burglars break into their own homes? Or is this time spent doing research, preparing plans, taking online training courses on emerging best practices,...more

McDermott Will & Emery

Five Key Considerations for Study Pre-Screening and Recruitment Initiatives in the Digital Age

McDermott Will & Emery on

Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Health Care Compliance Association (HCCA)

‘No More Boutique Studies’: NIH Mulls ‘Stopping Rules,’ Other Changes to Improve Clinical Trials

At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 5, May 2023

Cyber Resilience Programs Falling Short on Preparing Workers for a Crisis- “At two-thirds of organizations, there is a fear that almost all employees, 95%, will not understand how to recover following a cyberattack.” ...more

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more

Foley & Lardner LLP

White House Report Identifies Precision Medicine for Future R & D Investment

Foley & Lardner LLP on

Precision medicine was identified by a recent White House Office of Science and Technology Policy Report (“Report”) as a research and development priority for the United States over the next 20 years. The Report highlighted...more

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