The HIPAA Privacy Rule and COVID-19: Trends, Developments, and Compliance Issues in the Current Pandemic

2021-04-28T02:57:21-04:00

The current COVID-19 pandemic has created unprecedented challenges for health care providers and their business associates. This public health emergency has changed the way health care providers operate and deliver health care, including the increasing reliance on telehealth. Privacy officers for covered entities and their business associates need to keep abreast of notices and guidances issued by Department of Health and Human Services regarding compliance with Health Insurance Portability and Accountability Act (HIPAA) during this public health emergency.

The Hatch-Waxman and IPR Strategy in Light of Recent Case Decisions: Addressing Emerging Issues

2021-05-04T11:23:48-04:00

Inter partes review (IPR) proceedings have been an attractive ground for drug companies seeking to challenge the patentability of pharmaceutical products. The IPR allows challengers to maximize the streamlined process of the Patent Trial and Appeal Board (PTAB) while also taking advantage of the benefits provided by the Hatch-Waxman Act. Given this backdrop, the number of challenges utilizing the IPR process is predicted to continuously climb this year and beyond.

Food and Drug Regulatory Trends and Developments: Navigating Implications for the Year Ahead

2021-05-11T02:43:23-04:00

The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.

A Comprehensive Guide in Handling Medical Malpractice Claim: What You Should Know

2021-05-27T22:27:35-04:00

In this LIVE Webcast, a panel of thought leaders and professionals brought together by The Knowledge Group will provide and present an in-depth analysis of the fundamentals as well as recent developments in A Comprehensive Guide in Handling Medical Malpractice Claim: What You Should Know. Speakers will also present all important issues surrounding this significant topic. Join us for this Knowledge Group Webinar!

Revenue Cycle Management in the Healthcare Industry: Exploring Potentials and Pitfalls

2021-06-04T05:11:03-04:00

In this LIVE Webcast, a panel of thought leaders and professionals brought together by The Knowledge Group will provide and present an in-depth analysis of the fundamentals as well as recent developments in Revenue Cycle Management in the Healthcare Industry: Exploring Potentials and Pitfalls. Speakers will also present all important issues surrounding this significant topic. Join us for this Knowledge Group Revenue Cycle Management in the Healthcare CLE Webinar.

Biosimilars and the BPCIA: Exploring Trends, Developments, and Critical Issues

2021-05-06T21:15:13-04:00

As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.

HIPAA Security Rule and Security Risk Management: Addressing Threats and Vulnerabilities During the Pandemic

2021-03-26T04:21:46-04:00

The security risk analysis and management obligations required by the Health Insurance Portability and Accountability Act (HIPAA) Security Rule are intended to play a crucial role in mitigating risks and vulnerabilities to the security and confidentiality of patient protected health information (PHI). Organizations that fail to implement these measures may be more susceptible to potential PHI breaches and could be confronted with costly regulatory fines.

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