See Credit Details Below
Overview
Why You Should Attend
Technology has always been part of medicine. Digital health, AI, data analytics, and other new technologies present challenging legal issues for the companies that develop and sell these technologies and the health care institutions that buy and implement them. Often health care technologies companies buy technology to build their technology. Data is not technology and does not manage itself. When AI and data analytics are used as used as change agents, data and IT are combined to provide medical advances, and novel and complex issues come to the fore and must be addressed in the multi-use, multi-vendor, and multi-stakeholder environment that characterizes today’s health care institutions. Examine best practices for negotiating or renegotiating health care IT agreements; addressing intellectual property issues; handling AI and data, and tackling privacy and data security challenges. Our faculty of thought leaders will also look at the emerging legal issues and potential solutions to them, including over-the-horizon developments.
What You Will Learn
After completing the program, participants will be able to:
- Understand the importance of upgrading IT agreements for digital health
- Know the issues in drafting and negotiating IT agreements from the health care system – patient and health care organizations – perspectives and the health care technology company perspective
- Know factors to consider when creating a multiple vendor management ecosystem
- Address contract issues when “Big Tech” companies enter the health care field
- Diagnose critical considerations in data licensing, data sharing, data analytics, and data interoperability
- Recognize and assess issues related to implantables, wearables, and software-as-a-medical device
- Identify best practices for handling data protection, privacy and cybersecurity
Who Should Attend
This program is critical for in-house attorneys at health care organizations, companies that develop health care technology, life science companies and the private practice lawyers that advise them.
Program Level: Overview
Prerequisites: An interest in legal issues related to health care technology.
Advanced Preparation: None
Lecture Topics [Total time 00:06:45]
Segments with an asterisk (*) are available only with the purchase of the entire program.
- Opening Remarks* [00:04:41]
William A. Tanenbaum - Drafting and Negotiating Health Care System IT Agreements [01:06:35]
Diana J.P. McKenzie - Drafting and Negotiating Health Care Technology Company Agreements and Data Analytics Contracts [00:57:35]
William A. Tanenbaum - Data and Interoperability in Health Care [01:00:30]
Steven Lane, MD MPH, Deven McGraw - Gluing Multiple Vendors Together for a Better Health Care Vendor Management Ecosystem [01:00:11]
Jon Lightman - Health Care AI and Other Emerging Technologies in Health Care [01:00:38]
Ty Kayam, Jonelle Saunders - Health Care Cybersecurity, Privacy, and Data Protection [01:00:30]
Peter S. Vogel
The purchase price of this Web Program includes the following articles from the Course Handbook available online:
- Complete Course Handbook
- Drafting and Negotiating Health Care System IT Agreements (PowerPoint slides)
Diana J.P. McKenzie - Advising Healthcare Technology Companies: Buying Technology to Build Technology
Stephanie M. Smith,William A. Tanenbaum - Advising Healthcare Technology Companies: External Manufacturing and Supply Agreements
Stephanie M. Smith,William A. Tanenbaum - Introduction, Digital Healthcare 2022, Chambers Global Practice Guides, Chambers and Partners
William A. Tanenbaum - Background Resources for PLI Health Technology Program, “Data and Interoperability in Health Care”
Deven McGraw,Steven Lane - Frequently Asked Questions, Information Blocking, The Office of the National Coordinator for Health Information Technology (ONC), HealthIT.gov, available at: https://www.healthit.gov/faqs
Deven McGraw,Steven Lane - ISG, Healthcare Technologies: Care Management Goes Digital and Remote, available at: https://isg-one.com/industries/healthcare/articles/healthcare-technologies-care-management-goes-digital-and-remote
Jon Lightman - Robert (Bob) Krohn, ISG, Virtual Care Evolves Healthcare Beyond the Pandemic, available at: https://isg-one.com/industries/healthcare/articles/virtual-care-evolves-healthcare-beyond-the-pandemic
Jon Lightman - Building a Better Health Care Vendor Management Ecosystem?… Or How We Learn to Love Uncertainty (PowerPoint slides)
Jon Lightman - Introduction, Artificial Intelligence 2022, Chambers Global Practice Guides, Chambers and Partners
William A. Tanenbaum - U.S. Food and Drug Administration, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD), Discussion Paper and Request for Feedback (April 2019)
Jonelle Saunders,Ty Kayam - U.S. Food and Drug Administration, Center for Devices & Radiological Health, Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (January 2021)
Jonelle Saunders,Ty Kayam - U.S. Food and Drug Administration, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, Draft Guidance for Industry and Food and Drug Administration Staff (April 3, 2023)
Jonelle Saunders,Ty Kayam - California Department of Justice, Office of the Attorney General, Press Release, Attorney General Bonta Launches Inquiry into Racial and Ethnic Bias in Healthcare Algorithms (August 31, 2022), available at: https://oag.ca.gov/news/press-releases/attorney-general-bonta-launches-inquiry-racial-and-ethnic-bias-healthcare
Jonelle Saunders,Ty Kayam - U.S. Department of Health and Human Services, Press Release, HHS Announces Proposed Rule to Strengthen Nondiscrimination in Health Care (July 25, 2022), available at: https://www.hhs.gov/about/news/2022/07/25/hhs-announces-proposed-rule-to-strengthen-nondiscrimination-in-health-care.html
Jonelle Saunders,Ty Kayam - U.S. Department of Health and Human Services, Office of the Surgeon General, Confronting Health Misinformation: The U.S. Surgeon General’s Advisory on Building a Health Information Environment (2021)
Jonelle Saunders,Ty Kayam - Additional Resources: Health Care AI and Other Emerging Technologies in Health Care
Jonelle Saunders,Ty Kayam - Health Care Cybersecurity, Privacy, and Data Protection
Peter S. Vogel
Presentation Material
- Drafting and Negotiating Health Care System IT Agreements
Diana J.P. McKenzie - Contract Issues for Health Care Technology Companies
William A. Tanenbaum - Data and Interoperability in Health Care
Steven Lane, MD MPH, Deven McGraw - Building a Better Health Care Vendor Management Ecosystem?
Jon Lightman - AI and Other Emerging Technologies in Health Care
Ty Kayam, Jonelle Saunders
Technology has always been part of medicine. Digital health, AI, data analytics, and other new technologies present challenging legal issues for the companies that develop and sell these technologies and the health care institutions that buy and implement them. Often health care technologies companies buy technology to build their technology. Data is not technology and does not manage itself. When AI and data analytics are used as used as change agents, data and IT are combined to provide medical advances, and novel and complex issues come to the fore and must be addressed in the multi-use, multi-vendor, and multi-stakeholder environment that characterizes today’s health care institutions. Examine best practices for negotiating or renegotiating health care IT agreements; addressing intellectual property issues; handling AI and data, and tackling privacy and data security challenges. Our faculty of thought leaders will also look at the emerging legal issues and potential solutions to them, including over-the-horizon developments.
What You Will Learn
After completing the program, participants will be able to:
- Understand the importance of upgrading IT agreements for digital health
- Know the issues in drafting and negotiating IT agreements from the health care system – patient and health care organizations – perspectives and the health care technology company perspective
- Know factors to consider when creating a multiple vendor management ecosystem
- Address contract issues when “Big Tech” companies enter the health care field
- Diagnose critical considerations in data licensing, data sharing, data analytics, and data interoperability
- Recognize and assess issues related to implantables, wearables, and software-as-a-medical device
- Identify best practices for handling data protection, privacy and cybersecurity
Program Level: Overview
Prerequisites: An interest in legal issues related to health care technology.
Advanced Preparation: None