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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Wednesday, January 22, 2025

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.


  • Live Online


    On Demand

$297.00

This course is $0 with these passes:

CLE
ALL

This CLE webinar will provide a comprehensive overview of the permissible uses of health data for expansive business needs including research, artificial intelligence development, and commercial purposes under the HIPAA privacy rule. The panel will discuss the circumstances under which health data is considered protected health information (PHI) subject to the privacy rule and the requirements for using the data for these purposes. The panel will also offer best practices for remaining HIPAA compliant while meeting business needs.

Faculty

Erica L. Beacom
Attorney
Polsinelli

Ms. Beacom’s practice bridges FDA and healthcare enabling her to provide comprehensive, effective, and innovative legal solutions. She has developed a broad range of regulatory experience, representing clients in complex regulatory and administrative issues including navigating regulatory and policy matters involving the FDA and FTC; assisting parties in transactions based upon FDA-regulated products, including mitigation of FTC inquiries and other compliance challenges; counseling on advertising and promotional related issues and assisting clients in engaging with the regulatory process through federal submissions; structuring health care arrangements, including equity and asset purchases of pharmacies, home health agencies, hospices, and laboratories; counseling health care entities regarding reports to the National Practitioner Data Bank and state licensing boards; and assisting in responding to government or private contract inquiries, suspensions, or terminations of facility/individual enrollment or licensure.

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Shalyn Watkins
Attorney
Holland & Knight LLP

Ms. Watkins represents various healthcare providers and companies, including, but not limited to, individual providers and provider practices, long-term care and skilled nursing facilities, laboratories, technology companies, and insurers and health plans. Ms. Watkins also assists clients with developing and managing compliant healthcare programs. Her practice involves assisting clients with regulatory compliance, health information privacy advising, Medicare and Medicaid/Medi-Cal reimbursement and overpayment issues, licensure and credentialing disputes, and transaction due diligence and structuring. Ms. Watkins experience includes knowledge of the Health Insurance Portability and Accountability Act (HIPAA), corporate practice of medicine, Stark Law, Anti-Kickback Statute (AKS), Eliminating Kickbacks in Recovery Act (EKRA), contract disputes, administrative law and regulatory enforcement actions, compensation and policy reviews, and the development and implementation of compliance plans for clients.

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Description

Massive amounts of health data are now being collected for a variety of business uses including research, artificial intelligence development, and commercial purposes such as marketing. However, healthcare providers and their counsel should understand when health data is considered PHI and, therefore, subject to the HIPAA privacy rule and its requirements when using health data for these purposes in order to maintain compliance while meeting business needs.

For example, in general, covered entities may use and disclose PHI for research if authorized to do so by the subject in accordance with the privacy rule. However, the privacy rule permits covered entities to use and disclose PHI without authorization for certain types of research activities such as where a covered entity obtains documentation that an IRB or privacy board has waived the requirement for authorization or allowed an alteration. Furthermore, covered entities may use or disclose de-identified health information for research purposes without restriction under the privacy rule.

In addition to research activity, data is being used to develop artificial intelligence and is being commercialized, raising new compliance challenges.

Listen as our expert panel provides a comprehensive overview of the permissible uses of health information in relation to research, artificial intelligence, and commercialization, as well as the HIPAA requirements for using health data for these purposes in order to remain compliant.

Outline

  1. Introduction
    1. PHI overview
    2. Required vs. permissible PHI disclosures under HIPAA
  2. Permitted uses of PHI under HIPAA
    1. Research purposes
    2. Artificial intelligence development
    3. Commercialization/marketing
    4. De-identified health information
    5. Other
  3. Other federal and state privacy pointers
  4. Practitioner takeaways

Benefits

The panel will review these and other important considerations:

  • What are permissible uses of health data in research activity under HIPAA?
  • What challenges face covered entities when using health data for developing artificial intelligence?
  • Under what circumstances may health data be used for commercial purposes?
  • What other privacy considerations on the federal and state level outside of HIPAA should counsel be aware of?