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  • General Data Protection Regulation Series (GDPR), Part II - On Demand Recording

    Recorded On: 06/06/2019

    GDPR Implementation Challenges and Enforcement Actions; Similarities with CCPA

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    Everyone’s favorite four letter words...GDPR and CCPA. This session will take a closer look at GDPR implementation challenges and enforcement actions.  This panel will also discuss similarities between the GDPR and the California Consumer Privacy Act (CCPA), and will discuss the scope and key requirements of the CCPA.

    Level of Difficulty: Advanced

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Health Information and Technology Practice Group

    Partner(s):

    • Life Science Practice Group

    Farrell Wilkerson

    Senior Corporate Counsel

    Availity
    Jacksonville, FL
    Bio

    David Manek

    Senior Marketing Director

    Ankura
    Chicago, IL
    Bio

    Jody Erdfarb

    Partner

    Wiggin and Dana
    Stamford, CT
    Bio

  • Thought Leader Webinar: Less Drama, Better Decisions: The CIS Risk Assessment Method - On Demand Recording

    Recorded On: 06/05/2019

    How much security is enough? Business decision-makers juggle countless variables and make risk decisions using “due care” and “reasonableness.” The presentation reviews CIS® (Center for Internet Security) Risk Assessment Method (RAM), plus a worked example in detail.

    Time: 12:00-1:00 PM Eastern (60 minutes)
    Format: Live Webinar
    Topic:       

    How much security is enough? Business decision-makers juggle countless variables and make risk decisions using “due care” and “reasonableness.”  The presentation reviews CIS® (Center for Internet Security) Risk Assessment Method (RAM), plus a worked example in detail. The discussion is based on the Duty of Care Risk Analysis Standard (DoCRA) which helps organizations find the appropriate balance of compliance, safeguards, and business objectives for building their security strategy.

    Objectives for attendees:

    • Demonstrate how to balance the protection of their org’s interests with public interest in accordance with regulatory standards.
    • Establish definitions for “due care” to evaluate whether safeguards are reasonable and appropriate, either before or after a breach occurs.
    • Show how entities evaluated the risk-appropriateness of their safeguards after a breach occurs.
    • Learn a practical method of how to define 'appropriate'' or 'reasonable' risk."

    Note: No CLE offered for this course.

    What is "Reasonable"?

    HALOCK Security Labs partners with law firms to support clients for regulatory, strategic, and litigation matters using due care and reasonable person principles. HALOCK has pioneered an approach to risk analysis that aligns with regulatory standards for “reasonable” and “appropriate” safeguards and risk, and judicial “multifactor balancing tests” in data breach law suits. HALOCK has produced two emerging standards for cybersecurity risk management to promote our approach; the DoCRA Standard (Duty of Care Risk Analysis) maintained by the DoCRA Council, and CIS RAM (Risk Assessment Method) distributed by the prestigious Center for Internet Security.

    By partnering with HALOCK, law firms expertly advise and represent their clients on legal, regulatory, and strategic matters while effortlessly demonstrating how clients’ complex technical decisions are defensibly reasonable. Below are two resources to help you define "reasonable":

    Terry Kurzynski

    Board Member

    The DoCRA Council
    Senior Partner
    HALOCK Security Labs
    Schaumburg, IL
    Bio

    Jennifer L. Rathburn

    Founding Member

    Midwest Cyber Security Alliance
    Partner
    Foley & Lardner LLP
    Milwaukee, WI
    Bio

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    The DoCRA Council is a not-for-profit (501(C)(3)) organization that authors, maintains, and distributes standards and methods for analyzing and managing risk. The DoCRA Council is comprised of member organizations that require standards of practice in risk analysis and risk management, and who therefore have an interest in the methods used for analyzing risks and safeguards that reduce risk.

    The DoCRA Council operates under a charter that describes its methods of authorship, review, and stewardship of risk analysis standards and methods.

    Contact the DoCRA Council

    image

    When clients face cybersecurity challenges they need the right combination of experts to advise them. Cybersecurity risks are not exclusively a legal, business, or technical challenge. Risks can be created on corporate boards, in the C-Suite, within technical systems, or in the hands of end-users. Moreover, impacts can occur during a breach, or after a regulator reviews a case. And because cybersecurity risk and compliance is multi-disciplinary, advisors must capably address many specialized subjects at once to serve their clients well.

    Contact HALOCK for a Duty of Care Checklist and to help you determine the best course of action for you.

  • Where is My Hospital? New CMS Guidance Regarding Co-Location Changes the Game - On Demand Recording

    Recorded On: 06/05/2019

    Co-Location for Medicare-Certified Hospitals

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    Medicare-certified hospital spaces are precious…and hospitals share these approved spaces.  The Centers for Medicare & Medicaid Services (CMS) survey position regarding satisfying the Medicare conditions of participation for co-located hospitals has been developing in recent years.  On May 3, CMS issued new draft guidance that liberalized its survey position on this topic, and it is still subject to comment.  This webinar will cover the new draft guidance and discuss the implications for hospitals currently in co-located spaces, or considering entering into new arrangements of this type.

    Level of Difficulty: Intermediate

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Regulation, Accreditation, and Payment Practice Group

    Andrew Ruskin

    Partner

    Morgan Lewis
    Washington, D.C.
    Bio

    ​Lawrence W. Vernaglia

    Partner

    Foley & Lardner LLP
    Boston, MA
    Bio

    David R. Wright

    Acting Deputy Center Director

    Center for Clinical Standards and Quality
    Centers for Medicare & Medicaid Services
    Baltimore, MD

    Karen Tritz

    Director of our Division of Acute Care Services

    Centers for Medicare & Medicaid Services

    Danielle Miller

    Centers for Medicare & Medicaid Services

    Jeanne L. Vance (Moderator)

    Shareholder

    Salem & Green, A Professional Corporation
    Sacramento, CA
    Bio

  • New Hazardous Waste Pharmaceuticals Rule: Significant Changes Coming for Health Care Facilities, Particularly Long Term Care Facilities - On Demand Recording

    Recorded On: 06/04/2019

    Understanding EPA’s New Management Standards for Hazardous Waste Pharmaceuticals: What Health Care Providers Need to Know (and Do)

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    Understanding EPA’s New Management Standards for Hazardous Waste Pharmaceuticals:  What Health Care Providers Need to Know (and Do)

    In an effort to better align the Resource Conservation and Recovery Act (RCRA) standards for hazardous waste with the practical realities of how hazardous waste pharmaceuticals are managed in the health care facility setting, the U.S. Environmental Protection Agency recently promulgated a final rule that establishes a completely new set of management standards for hazardous waste pharmaceuticals in health care facilities. The rule also prohibits the sewering of hazardous waste pharmaceuticals and deletes the hazardous waste listing for certain nicotine replacement therapies.  
    The rule applies to a broad array of health care facilities, including hospitals, long-term care facilities, pharmacies, reverse distributors, and others.  While the new requirements present a compliance challenge for all health care facilities covered by the rule, long-term care facilities will face the greatest challenge as they, for the first time, will be required to manage not only their hazardous waste pharmaceuticals, but also their non-pharmaceutical hazardous waste, in accordance with RCRA requirements.
    Join your colleagues for an engaging discussion of the requirements of the EPA Hazardous Waste Pharmaceuticals Rule and what the rule means for health care facilities in general, but especially for long-term care facilities.


    Level of Difficulty: Intermediate

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Post-Acute and Long Term Services Practice Group

    Jennifer Hilliard

    Attorney

    Arnall Golden Gregory, LLP
    Washington, DC
    Bio

    Ralph DeMeo

    Shareholder

    Baker Donelson
    Tallahassee, FL
    Bio

  • Straight from the Source: Antitrust Implications and Lessons Learned from the Washington AG v. CHI Franciscan Case - On Demand Recording

    Recorded On: 05/30/2019

    Almost two years ago, healthcare providers and those in the antitrust bar sat up and took notice when the Washington Attorney General’s office filed a complaint against CHI Franciscan, alleging that the not-for-profit health system’s 2016 transactions with two Kitsap Peninsula physician groups violated the antitrust laws. The State’s lawsuit asked the Court to unwind both transactions and impose millions in civil penalties and equitable monetary relief for ill-gotten gains on all Defendants. The case was another reminder that antitrust enforcers will pay close attention to physician group acquisitions and affiliations regardless of size. But this case had a unique twist from its progeny: the State challenged one of the transactions as a per se illegal price fixing arrangement and the other as an illegal merger. This approach presented legal issues beyond those present in traditional merger challenges, such as the single entity defense and whether the court should apply the per se, quick look, or rule of reason analysis. This lawsuit was also filed as an AG-only action, unlike many healthcare merger challenges that involve both federal and state enforcers.

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    Almost two years ago, healthcare providers and those in the antitrust bar sat up and took notice when the Washington Attorney General’s office filed a complaint against CHI Franciscan, alleging that the not-for-profit health system’s 2016 transactions with two Kitsap Peninsula physician groups violated the antitrust laws.  The State’s lawsuit asked the Court to unwind both transactions and impose millions in civil penalties and equitable monetary relief for ill-gotten gains on all Defendants.  The case was another reminder that antitrust enforcers will pay close attention to physician group acquisitions and affiliations regardless of size.  But this case had a unique twist from its progeny:  the State challenged one of the transactions as a per se illegal price fixing arrangement and the other as an illegal merger.  This approach presented legal issues beyond those present in traditional merger challenges, such as the single entity defense and whether the court should apply the per se, quick look, or rule of reason analysis.  This lawsuit was also filed as an AG-only action, unlike many healthcare merger challenges that involve both federal and state enforcers.
     
    Our panel includes lawyers for both the State and Defendants, and promises to provide an “in the trenches” vantage point on the key issues of the case, such as: 

    • Why does structure of a physician group transaction matter?
    • What’s evidence of anticompetitive harm?
    • What’s the relevance of a physician group that’s in poor financial condition?
    • Is Kaiser part of the relevant market?
    • How important is a strong structural case? (high market shares / concentration level)  

    This program is a “must” for healthcare antitrust lawyers and for anyone interested in hospital-physician transactions.

    Level of Difficulty: Intermediate

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Antitrust Practice Group

    Douglas E. Litvack

    Partner

    Davis Wright Tremaine LLP
    Washington, DC
    Bio

    Erica Koscher

    Assistant Attorney General

    Washington State Office of the Attorney General
    Seattle, WA

    ​Ashley M. Fischer (Moderator)

    Partner

    McDermott Will & Emery LLP
    Chicago, IL
    Bio

  • Conducting Peer Review Under PSQIA Protection - On Demand Recording

    Recorded On: 05/28/2019

    This Webinar will discuss the statutory and regulatory framework that supports using Patient Safety and Quality Improvement Act (PSQIA) protection for professional peer review, and will address the impact of emerging case law on those protections. In addition, we will provide real-world examples of how peer review is being protected successfully under the PSQIA, and offer practical “dos and don’ts” for providers seeking to use PSQIA protection for professional peer review.

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    This Webinar will  discuss the statutory and regulatory framework that supports using Patient Safety and Quality Improvement Act (PSQIA) protection for professional peer review, and will address the impact of emerging case law on those protections.  In addition, we will provide real-world examples of how peer review is being protected successfully under the PSQIA, and offer practical “dos and don’ts” for providers seeking to use PSQIA protection for professional peer review.

    Level of Difficulty: Intermediate

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Medical Staff, Credentialing, and Peer Review Practice Group

    ​Robin Locke Nagele (Moderator)

    Principal & Co-Chair

    Health Care Practice Group
    Post & Schell PC
    Philadelphia, PA
    Bio

    Peggy Binzer, JD.

    Executive Director

    Alliance for Quality Improvement and Patient Safety
    Bio

    Evelyn Baram Clothier, Ph.G, JD.

    Executive Director

    American Medical Foundation for Peer Review and Education


    Evelyn Baram-Clothier, a pharmacologist and attorney, has been involved in legal medicine and peer review since 1971.  Until 1986, she was the Executive Director for a group of 250 physician attorneys who acted as a national malpractice-screening panel, which became the first national consulting firm in medical staff peer review.  In the field of medical litigation, she was the managing partner of a law practice of physician-attorneys and was consultant and co-counsel to some of the nation’s leading trial lawyers until 1985.   
     
    In response to the enactment of HCQIA in 1986, she partnered with Dr. Richard Wilbur, the Executive Vice President of the Counsel of Medical Specialty Societies, to form the American Medical Foundation for Peer Review & Education (AMF), a 501-C3 non-profit national foundation, devoted to hospital and medical staff peer review and onsite physician education through its Division, The Foundation for Advanced Medical Education (FAME).  

    Evelyn Baram-Clothier has extensive experience in the design and implementation of peer review in virtually every specialty of medicine and surgery.  She administers practice reviews of individual physicians, specialty departments and helps to create hospital-wide systemic improvements with medical staff leadership to effectively address complex peer review issues. Working with many different medical and surgical specialists, she has improved the quality of care through peer review in thousands of hospitals nationwide.  AMF is the only non- profit organization experienced in the unique problems of academic institutions, such as department reorganization and the complex attending and residency issues.

    She has been responsible for the peer review of catheterization laboratories, major cardiac surgical and other surgical services, emergency departments, pathology and radiology departments and other service lines hospital wide. She has assisted hospitals and attorneys in various investigations involving Medicare issues and OIG related matters. AMF has served as the Institutional Review Organization for a hospital under a Corporate Integrity Agreement.

    She has chaired several national programs on hospital administration and liability, peer review, malpractice and medical products liability and preventive law, for ALI-ABA, and is a life member of the American Law Institute. She is AV rated with Martindale-Hubbell.  

    She chaired the first "Anglo-American Conference on Medical Standards, Peer Review, Audit and Accountability” for the Royal Society of Medicine London 1990. She is a Fellow of the Royal Society of Medicine and for many years was Vice President of its Foundation.

    She is a Fellow of the  American Academy of Forensic Sciences, was Chairman of its General Section and Program Chairman: "The Second Gun," Forensic Examination into the Death of Robert F. Kennedy; sponsored by the American Academy of Forensic Sciences, Chicago 1975.

    She was Chairman: of the first  "National Conference on Medical Devices and Drugs." in March 26, 27, 1976 , during the formation of the Bureau of Medical Devices and became the Consumer Representative for the Department of Health, Education and Welfare, Bureau of Medical Devices: Neurological Device Classification Panel, 1978-1981.

    In 1985, she was appointed by President Ronald Reagan to be the United States Delegate to the International Conference on Drug Abuse and Illicit trafficking in Vienna.

    Recent Lectures

    (Complete list upon request)

    Keynote Speaker: The Federation of State Medical Boards 100th Anniversary Meeting, the Bryant Galusha Lecture, “The Benefits of Telementoring on Post Graduate Physician Education, Patient Outcomes and Patient Safety, April 28th 2012.
    Keynote Address: “Telementoring and Post Graduate Physician Education”, the Annual Meeting of the Council of Medical Specialty Societies, November 19, 2012.
    Presentation at the 3rd International Conference on Transforming Healthcare and IT Meeting, Hyderabad, India, “The Benefits of Telementoring on Post Graduate Physician Education, Patient Safety and Patient Outcomes”, August 2012.
    Presentation to the Medical and Surgical Staff, Ganga Ram Hospital, New Delhi, India.  The Benefits of Telementoring on Post Graduate Physician Education, Patient Safety and Patient Outcomes”, September 2012.

    Bibliography
    (Complete list upon request)
    "Multiple Drug Therapy-Is There a Standard of Care? Journal of Legal Medicine, . 1977,.
    "Multiple Drug Therapy- Is There a Standard of Care?" The Influence of Litigation of Medical     Practice, Royal Society of Medicine, London, May 1977
    "Peer review in the USA-an old concept and a new method" International Congress and Symposium Series Medical Audit and Accountability, Royal Society of Medicine Service Limited, London, New York, 1992.
    .“The Society of Thoracic Surgeons/American Association for Thoracic Surgery Off-Pump     Training Program”  Richard P. Anderson, MD, Meghan Carey, MSW, Evelyn Baram-    Clothier, JD, Michael J. Mack, MD, and Bruce W. Lytle, MD.  The Annals of Thoracic     Surgery, 2005.
    Siegle, Robert L, Baram, Evelyn M, Reuter, Stewart, R, Clarke, Ewell A, Lancaster, Jack L., McMahan, C Alex: Rates of disagreement in imaging interpretation in a group of community hospitals. Acad. Radiol., 1998; 5:148-154
    Merritt C, Baram-Clothier E: Image interpretation discrepancy rates measured by external peer review. Presented at Meetings of the American College of Radiology (2010) and the Amer¬i¬can Roent¬gen Ray Soci¬ety in (2011) Publication Pending
    Anderson, Richard P, Carey, Meghan, Baram-Clothier, Evelyn, Mack, Michael J, Lytle, Bruce W: The Society of Thoracic Surgeons/American Association for Thoracic Surgery Off-Pump Training Program. The Annals of Thoracic Surgery, accepted for publication, 2005

    Eisenhauer A, Cutlip D, Baram-Clothier E: Making Peer Review Painless. Cath Lab Digest, June 2013; 21(6):10-14
    Baram-Clothier E. Editor: Surgical Telementoring News. 2015
    Nguyen N, Okrainec A, Anvari M, Smith B, Meireles O, Gee D, Moran-Atkin E, Baram-Clothier E, Camacho D: Sleeve gastrectomy telementoring: a SAGES multi-institutional quality improvement initiative, Surg Endosc, July 2017; 1-6

  • MSCPR and National Association Medical Staff Services (NAMSS) Webinar Series, Part I - On Demand Recording

    Recorded On: 05/23/2019

    Physician Burnout and the Physician Well-Being Committee (PWBC)

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    How does physician fatigue and burn out contribute to quality/safety issues, disruptive conduct, impairment and other medical staff challenges?   This Webinar will address the legal and practical challenges arising from physician burnout, and what gets hospitals and physicians into trouble.  It will provide practical pointers on the design and operation of a Physician Well Being Committee as a means of addressing these issues on the medical staff.

    Level of Difficulty: Intermediate

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Medical Staff, Credentialing, and Peer Review Practice Group

    Partner(s):

    • National Association Medical Staff Services (NAMSS)

    Barbara Blackmond (Moderator)

    Partner

    Horty Springer & Mattern PC
    Pittsburgh, PA
    Bio

    Lou Ann Brindle

    NAMSS - National Association Medical Staff Services
    Pittsburgh, PA
    Bio

    Michael Genovese, MD JD

    Genovese Medical

    Nashville, TN
    Bio

    Casey Duhart, Esq.

    Associate

    Waller Lansden

    Nashville, TN
    Bio

  • Digital Therapeutics: Emerging Legal, Regulatory, and Ethical Issues - On Demand Recording

    Recorded On: 05/22/2019

    Evidence-based digital therapeutics promise to improve health care quality, outcomes, and value through the use of advanced technology and data-driven interventions.

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    This session will cover the following:

    • Evolving business models for digital therapeutics companies (and associated legal/regulatory issues)
      • direct-to-consumer
      • Digital providers/ .
      • partnerships/business arrangements (several examples of partnerships/business arrangements between big pharma, big data, payors, and startups)
    • Areas of Medicine Best Positioned for Digital Therapeutics
      • chronic diseases/behavioral
      • high-data/multifactorial diagnoses
      • other
    • Key legal/regulatory issues for digital therapeutics companies (FDA, FTC, privacy and security, fraud and abuse, and reimbursement)
    • Physician/Provider Use of Digital Therapeutics (and associated legal/regulatory issues)
      • standard of care
      • agreements between physicians/providers and digital therapeutics companies

    • Digital therapeutic providers supplying healthcare: contracting, status, obligations, risks. {This may be subsumed in "key legal/regulatory issues}.
    • The Future of Digital Therapeutics
      • emerging legal/regulatory and ethical issues (and some predictions)

    Level of Difficulty: Advanced

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • Life Sciences Practice Group

    Ryan Johnson

    Shareholder

    Fredrikson & Byron, P.A.
    Minneapolis, MN
    Bio

    Lucia Savage

    Chief Privacy & Regulatory Officer

    Omada Health
    Bio

  • Leveraging LinkedIn: Optimizing the Tool for Leads - On Demand Recording

    Recorded On: 05/21/2019

    Learning objectives include: How to make a great first impression What profile content matters? How to monitor your profile's performance How you should be networking within LinkedIn Additional tactics to leverage this tool

    Time: 12:00-1:00 PM Eastern (90 minutes)
    Format: Live Webinar
    Topic:       

    Learning objectives include:

    • How to make a great first impression
    • What profile content matters?
    • How to monitor your profile's performance
    • How you should be networking within LinkedIn
    • Additional tactics to leverage this tool

    Note: No CLE offered for this course.

    Content Lead:

    • Governance Affinity Group and AHLA

    Leslie Lewis

    Director of Client Service

    Willow Marketing
    Indianapolis, IN
    Bio

  • The General Counsel Series Part II - On Demand Recording

    Recorded On: 05/16/2019

    Contract Management and Compliance Best Practices

    Time: 90 minutes
    Session Format: On Demand Recording
    CLE Credit Available:  No

    For on-demand webinar recordings, streaming access is available for 12-months from the date of the live webinar.  After 12-months, on-demand webinar recordings are available through the AHLA Health Law Archive.

    This webinar will discuss record retention, policies, Fair Market Value documentation, enforcements, technology, turnaround times, policies, coordinating with compliance departments and much more.

    Level of Difficulty: Intermediate

    • AHLA Member: $99
    • Non-AHLA Member: $149

    Content Lead:

    • In-House Counsel Practice Group

    Partners:

    • Public Health System Affinity Group
    • Business Law and Governance Practice Group
    • Fair Market Value Affinity Group

    David H. Ellenbogen

    General Counsel

    Scott & White Health Plan
    Austin, TX 

    Andrea Ferrari JD, MPH

    Partner

    Health Care Appraisers
    Boca Raton, FL
    Chair, Public Health Systems Affinity Group
    Bio

    Sarah Swank (Moderator)

    Counsel

    Nixon Peabody LLP
    Washington, DC
    Bio

    Alaina N. Crislip, MPH, JD,

    Associate General Counsel

    Thomas Health System, Inc.
    Charleston, WV
    Bio