U.S. Senate Finance Committee Hearing on AI in Health Care Shows AI Policy is Forthcoming
The U.S. Senate Finance Committee held a February 8, 2024 hearing titled “Artificial Intelligence and Health Care: Promise and Pitfalls.”
The U.S. Senate Finance Committee held a February 8, 2024 hearing titled “Artificial Intelligence and Health Care: Promise and Pitfalls.”
The following witnesses testified at the hearing:
Peter Shen, Head of Digital & Automation for North America, Siemens Healthineers, Washington, DC
Mark Sendak, MD, MPP, Co-Lead, Health AI Partnership, Durham, NC
Michelle M. Mello, JD, Ph.D., Professor of Health Policy and of Law, Stanford University, Stanford, CA
Ziad Obermeyer, MD, Associate Professor and Blue Cross of California Distinguished Professor, University of California – Berkeley, Berkeley, CA
Katherine Baicker, Ph.D., Provost, University of Chicago, Chicago, IL
Senator Wyden (D-OR) made a few statements on AI. The Senator emphasized the importance of ensuring that AI in healthcare is used to improve patient outcomes and lower costs, rather than being driven by profit.. He also highlighted the need to address concerns regarding privacy, data security, and bias in AI algorithms.
Artificial Intelligence is clearly an emerging innovative field that is both exciting and risky. For tech and healthcare stakeholders, the possibilities can be endless when examining potential legal and regulatory pitfalls.
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and technology spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
How to Choose a Lobbyist
Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization?
Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization?
First you want to make sure the lobbyist has experience. To be a good lobbyist there is no magic number of how many years you have worked within the political system. However; many lobbyists have worked an average of six months in the legislature as an aide to a legislator or on the other side of the spectrum, many legislators have left the legislature to work as a lobbyist. These individuals have an insider’s perspective into how the legislature works such as when a bill filing deadline date is and whether or not a bill can be introduced due to if a state is in an emergency session where the rules for introducing legislation is different from regular session.
Second the lobbyist should have a minimum number of contacts in the legislature. Whether it is in Congress or on the state level, the lobbyist should be able to have a go to legislator that can get a bill introduced quickly. However; the most successful lobbyist will not be limited to one party. Having contacts on both sides of the aisle will allow the lobbyist the opportunity to bring any bill at any time regardless of what political party has the majority.
Third the best lobbyist should be strategic. He or she should be able to know when a good time to introduce legislation is. The lobbyist should know what legislator to target as the bill sponsor. This is important because the bill sponsor will be the champion for your particular bill from start to finish. The lobbyist will need to educate the bill sponsor on the nuances of the bill so that the sponsor will be educated enough to be able to respond to technical questions during a hearing or when the sponsor is in caucus meetings; explaining to their respective party about why your bill should be voted on. The lobbyists should be able to pick and choose what committee will be best for your bill to go into, who to use as strategic allies for your legislation and be intuitive enough on when to negotiate and when not to.
Next it is important for your lobbyist to know the industry and to have foresight. You need to be comfortable knowing that your lobbyist understands your industry because if not, how can you be sure that your lobbyist is communicating the correct outcome for you? The lobbyist should be skilled enough to draft a bill that solves your problem without having to continuously ask you how something works. Additionally, while many lobbyists only focus on the legislature, the best lobbyists will think long-term to determine if a regulatory body will be involved once your bill passes. If so a lobbyist should be able to guide you through the regulatory process without leaving you to fend for yourself after a bill has passed.
Finally, as with any other professional, you need to be aware of the reputation your lobbyist has. Do they take the time to make sure their clients understand everything that is happening? Does the lobbyist prepare the client and relevant legislators ahead of time for crucial hearings? Does the lobbyist make everything easy to understand? Does the lobbyist dress appropriately for meetings and do they have the needed respect from the legislature? Does the lobbyist closely follow the bill from start to finish or are they overloaded with too many clients? These are important issues to talk with your prospective lobbyist about before entering into a contractual relationship.
While there are other nuances to the lobbying relationship, these should be enough for you to think about as your organization considers whether to engage a lobbyist. Lobbyist should no longer be considered a luxury item. The best lobbyist are quickly becoming essential parts of today’s corporate environment for the value they bring to their clients in either advancing their interests through legislation, or being available to respond to legislative targeting that has been on the rise. You know you have picked the right lobbyist when you can breathe a sigh of relief knowing that they have your back.
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. We help stakeholders understand what’s at issue so that we can help our valued clients achieve their priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
FDA Announces the Launch of its Digital Health Center of Excellence
With all the attention on the 2020 elections, what may have been lost in the fray was the announcement that the FDA created the Digital Health Center of Excellence, within the Center for Devices and Radiological Health (CDRH). According to the FDA’s release, the new Center is dedicated “to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”
With all the attention on the 2020 elections, what may have been lost in the fray was the announcement that the FDA created the Digital Health Center of Excellence, within the Center for Devices and Radiological Health (CDRH). According to the FDA’s release, the new Center is dedicated “to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”
So what is the mission of the Digital Health Center of Excellence? According to the FDA:
“The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.”
As COVID 19 has forced our society to become more mobile and technologically dependent, the trends of big data, AI, machine learning and mobile health to name a few are here to stay.
Lanton Law is an innovative firm that sees itself at the center of tomorrow’s legal, policy and market trends. We continue to monitor the developments of emerging sectors and give counsel to stakeholders in highly regulated industries. If you are a stakeholder examining your options for this year and need advice, contactLanton Law to discuss yourlobbying andlegal strategies.