K&L Gates Health Care Triage

K&L Gates
  • 0.0 (0)
  • BUSINESS
K&L Gates Health Care Triage Podcast

Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.

  1. 9 APR

    Corporate Practice of Medicine: New Relevance in a Changing World

    In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine and other remote models has become heavily adopted: Corporate Practice of Medicine, or “CPOM.” As more and more health care companies look for innovative ways to deliver healthcare, it can be easy for seasoned healthcare professionals and newcomers alike to discount or dismiss CPOM. While on its face it is a straightforward prohibition, it is important to understand the doctrine’s underlying philosophy and to appreciate its complexity, particularly how it varies from state to state. This is particularly the case where telehealth has become an established method for the delivery of care, and many new companies are entering the health care space. As health care entities, health IT solutions providers, and other companies seek to deliver care in one or more states, there are many health care regulatory considerations to consider, but CPOM should be at the top of the list.  In part one of this series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton offer a brief primer on CPOM, answer some practical questions about its impact, and elaborate on its present-day relevance for health care providers and other companies.

    29 min

  2. 1 APR

    Health System Cybersecurity Risks: Part Two

    In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The Department of Health and Human Services’ Office for Civil Rights (OCR) reports a nearly 300% increase in large data breaches that involve ransomware reported to OCR from 2018 to 2022. Interoperability remains a major government priority, and as remote care models continue to proliferate and the need intensifies for big data to feed increasingly complex technologies, risks to health care providers will continue to abound.   In part two, Gina Bertolini and Sarah Carlins discuss HHS’s “Healthcare Sector Cybersecurity” report, which outlines HHS’s strategy for securing the digital infrastructure of our nation’s health care system. HHS’s strategy includes increased funding for support and enforcement of HIPAA’s Security Rule and the implementation of voluntary Cybersecurity Performance Goals, and HHS projects changes to HIPAA’s Security Rule coming in the Spring of 2024.

    23 min

  3. 26 MAR

    Health System Cybersecurity Risks: Part One

    In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The Department of Health and Human Services’ Office for Civil Rights (OCR) reports a nearly 300% increase in large data breaches that involve ransomware reported to OCR from 2018 to 2022. Interoperability remains a major government priority, and as remote care models continue to proliferate and the need intensifies for big data to feed increasingly complex technologies, risks to health care providers will continue to abound.   In part one of this series, Sarah Carlins and Jianne McDonald discuss recent OCR recommendations for healthcare providers and patients on cybersecurity measures when providing and receiving care via telehealth. They also discuss the federal government’s view that effective communication regarding the privacy and security of electronic health information is an important component of quality care in the telehealth setting.

    11 min

  4. 5 MAR

    Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast

    In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA’s final rule on IRB waivers of consent, the IRB review of individual patient expanded access submissions, and the potential effects of the new proposed rule for lab developed tests.

    16 min

  5. 12/10/2023

    FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

    In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.

    15 min

  6. 08/09/2023

    Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations

    In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agency initiative to help create security tools to protect the US health care system from cyberattacks.

    13 min

  7. 22/08/2023

    Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement

    In this episode, Darlene Davis, Leah Richardson, and Andrew Ruskin unravel CMS’s proposed rule for the remedy for Medicare payments for drugs purchased under the 340B Program and reimbursed as hospital outpatient services. The discussion includes background of the unlawful 340B drug reimbursement policy, as well as CMS’s proposed remedy. They also discuss the way in which CMS suggests that it will adjust future payments as a purported countermeasure for its remedy payments, as well as the implications for ongoing Medicare Advantage plan disputes on the same issues.

    18 min

  8. 12/07/2023

    The End of Continuous Medicaid Enrollment—What Health Systems Should Know

    In this episode, Alexander Chu and Ashley Davis review the end of the continuous Medicaid enrollment condition as a result of the Consolidated Appropriations Act, 2023. They discuss potential impacts of the disenrollment process for health care providers and provide helpful tips for health systems to navigate this change.

    6 min
See All (143)

About

Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.

Information

  • Creator
    K&L Gates
  • Years Active
    2017 - 2024
  • Episodes
    143
  • Rating
    Clean
  • Copyright
    © 2019 K&L Gates LLP. All Rights Reserved
  • Show Website
    K&L Gates Health Care Triage

To listen to explicit episodes, sign in.

Stay up to date with this show

Sign in or sign up to follow shows, save episodes and get the latest updates.
Select a country or region

Africa, Middle East, and India

Asia Pacific

Europe

Latin America and the Caribbean

The United States and Canada