Bipartisan Bill Aimed At Expanding CMS Coverage Of Rx Digital Therapeutics Re-Introduced

The Access to Prescription Digital Therapeutics Act of 2025 (S1702/3288) seen here has been re-introduced by Senators Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH)) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA).

The Access to Prescription Digital Therapeutics Act of 2025 (S1702/3288) seen here has been re-introduced by Senators Shelley Moore Capito (R-WV) and Jeanne Shaheen (D-NH)) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA). The proposed legislation would do the following: 

  • Create a reimbursement pathway for software that treats medical conditions

  • Create a new Medicare benefit category for Food and Drug Administration (FDA)-cleared prescription digital therapeutics to be prescribed to seniors in the program.

  • Require the CMS to develop payment methodologies for prescription digital therapeutics and create product-specific CPT codes to adequately reimburse for the products. 

Lanton Law through its Government Affairs Division Lanton Strategies has been following digital therapeutic policy as it unfolds. This is an oftentimes confusing area of policy since it is innovative and many times mistakenly tied to FDA approvals. 

Stakeholders who are interested in this issue and want to ensure compliance should ensure that an adequate and appropriate FDA approval and CMS reimbursement strategy is in place internally to avoid marketplace delays. Contact us to learn more.  

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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.

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Congress Reintroduces the Access to Prescription Digital Therapeutics Act

Congress has introduced The Access to Prescription Digital Therapeutics Act of 2023

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise. 

With that in mind, Congress has introduced The Access to Prescription Digital Therapeutics Act of 2023. The bill proposes to “expand Medicare coverage to include PDTs, which are software-based disease treatments designed to directly treat disease. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software. The treatments are tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA) and prescribed by health care providers.” The bill can be read here.

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

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What is Remote Patient Monitoring (RPM)?

Remote patient monitoring is an innovative way that healthcare providers are using to treat chronic and acute conditions. With COVID-19 spurring faster adoption of telehealth and RPM, the subject of RPM involves the connection of digital tools that record healthcare data that is reviewed by an off-site provider.

What is Remote Patient Monitoring (RPM)?

Remote patient monitoring is an innovative way that healthcare providers are using to treat chronic and acute conditions. With COVID-19 spurring faster adoption of telehealth and RPM, the subject of RPM involves the connection of digital tools that record healthcare data that is reviewed by an off-site provider. According to HHS, new treatment methods like RPM can help with the following conditions:

  • High blood pressure

  • Diabetes

  • Weight loss or gain

  • Heart conditions

  • Chronic obstructive pulmonary disease

  • Sleep apnea

  • Asthma

Many of the devices that patients will use may be familiar to them, including:

  • Weight scales

  • Pulse oximeters

  • Blood glucose meters

  • Blood pressure monitors Telehealth.hhs.gov

At Lanton Law we have been monitoring the both exciting and emerging field of RPM. We fully anticipate the conversation to continue to evolve into further regulatory definitions as well as appropriate reimbursement schemes. 

Lanton Law is a national healthcare and technology boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like RPM, RTM and digital therapeutics so that we can help our valued clients. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

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U.S. House passes legislation to extend telehealth waivers through 2024

The U.S. House of Representatives has passed passed the Advancing Telehealth Beyond COVID-19 Act of 2022 (H.R. 4040). The bill proposes to extend telehealth flexibilities under Medicare that were initially authorized during the public health emergency of COVID-19. The bill heads to the U.S. Senate.

The U.S. House of Representatives has passed passed the Advancing Telehealth Beyond COVID-19 Act of 2022 (H.R. 4040). The bill proposes to extend telehealth flexibilities under Medicare that were initially authorized during the public health emergency of COVID-19. The bill heads to the U.S. Senate. 

Specifics of the proposal are as follows:

  • Provides that certain flexibilities continue to apply until December 31, 2024, if the emergency period ends before that date. 

  • Beneficiaries to continue to receive telehealth services at any site, regardless of type or location (e.g., the beneficiary's home); 

  • Occupational therapists, physical therapists, speech-language pathologists, and audiologists to continue to furnish telehealth services;

  • Federally qualified health centers and rural health clinics to continue to serve as the distant site (i.e., the location of the health care practitioner);

  • Evaluation and management and behavioral health services to continue to be provided via audio-only technology; and

  • Hospice physicians and nurse practitioners to continue to complete certain requirements relating to patient recertifications via telehealth.

The bill also delays implementation of certain in-person evaluation requirements for mental health telehealth services until January 1, 2025, or the first day after the end of the emergency period, whichever is later.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

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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.

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UnitedHealthcare (UHC) Announces Virtual Physical Therapy Program

UHC has announced a partnership with Kaia Health on a new virtual physical therapy program. The program is aimed at shoulder or knee problems and other musculoskeletal issues.

UHC has announced a partnership with Kaia Health on a new virtual physical therapy program. The program is aimed at shoulder or knee problems and other musculoskeletal issues. 

How does it work? 

According to the announcement  “The app uses a front-facing smartphone camera and artificial intelligence technology to analyze a user’s movement patterns while performing PT exercises. The program gives real-time tips for carrying out safe, effective exercise sessions that typically last between 10-25 minutes. If, at any point, a certified health coach is needed, one can be accessed using an in-app chat feature.

The app is part of a broader set of in-person and virtual musculoskeletal support tools available to eligible UnitedHealthcare members recovering from surgery or injury, including knee, back or shoulder problems. The programs are designed to help improve health, reduce costs and avoid often unnecessary invasive treatments, including imaging, surgery or opioid prescriptions.”

We continue to see emerging innovation within healthcare around digital healthcare and digital therapeutics. Opportunities abound for those looking for new ways to care for patients. 

Lanton Law is an innovative firm at the center of tomorrow’s legal, policy and market trends. We continue to monitor the developments of emerging sectors such as digital healthcare and give counsel to stakeholders accordingly. Contact Lanton Law to discuss your lobbying and legal strategies.     

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

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Prescription Digital Therapeutics Presses Ahead for Behavioral Health

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise.

At Lanton Law we have been monitoring the both exciting and emerging field of prescription digital therapeutics. While the technologies we have been witnessing are promising, there does remain the challenge of reimbursement, since there has not yet been a statutory benefit category established for this new technology. However; behavioral health shows the most immediate promise. 

A recent CMS meeting illustrates this point. CMS released a document titled “Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations” for the Second Biannual, 2021 HCPCS Coding Cycle. The document can be viewed here. The document describes Pear Therapeutics’ reSET-O which is a “12-week interval prescription digital therapeutic for opioid use disorder (OUD).” CMS’ examination ended with its decision effective April 1, 2022 to establish a HCPCS Code to “facilitate options for non-Medicare payers to provide access to this therapy in the home setting,” so that CMS can continue its marketplace monitoring. This on top of the AMA’s CPT Editorial Panel’s actions (seen here) to establish a new CPT code for Cognitive Behavioral Therapy Monitoring effective January 2023 shows that there will definitely be more certainty in this field in the next coming years. 

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

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President Biden Issues Executive Order Aimed at Multiple Industries

President Biden has issued an Executive Order (EO) titled Executive Order on Promoting Competition in the American Economy.

President Biden has issued an Executive Order (EO) titled Executive Order on Promoting Competition in the American Economy. The EO advocates for promoting “competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.” In doing so multiple sectors of the economy including labor, healthcare, transportation, agriculture, communications, technology, banking and finance have been targeted.    

As our economy emerges from the pandemic, we foresee that state and federal policymakers will be taking a look to see what laws need to be strengthened or reworked for our reimagined economy. 

Lanton Law is a national boutique law and lobbying firm that focuses on highly regulated industries such as healthcare, technology, and finance. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

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Protecting Rural Telehealth Access Act Introduced

Via a recently released a press release describing how a group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent.

Via a recently released a press release describing how a  group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent. 

“This legislation would ensure rural and underserved community healthcare providers are able to continue offering telehealth services after the current public health emergency ends. These services include the ability to offer audio-only telehealth appointments because many rural Americans don’t have reliable, affordable broadband access.”

According to the press release the proposed Act would: 

  • Allow payment-parity for audio-only health services for clinically appropriate appointments. During COVID-19, recognizing not everyone has access to the technology in their home, Congress made allowances for audio-only telephone services to be used to allow doctors to reach patients wherever they are.

  • Permanently waive the geographic restriction allowing patients to be treated from their homes. Pre-COVID-19, the home was allowed as an eligible originating site in Medicare and some Medicaid programs, but only for very specific services, and only for the patient, not the provider.

  • Permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services.

  • Lift the restrictions on “store and forward” technologies for telehealth. Currently this is only allowed in Hawaii and Alaska. 

  • Allows Critical Access Hospitals (CAHs) to directly bill for telehealth services.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our telepharmacy practice has been helping pharmacies and physicians with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

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Verizon Enters the Telehealth Market

According to a Verizon press release, the company announced its new telehealth venture called BlueJeans Telehealth.

According to a Verizon press release, the company announced its new telehealth venture called BlueJeans Telehealth. 

“According to the “The Future of Telehealth - Balancing Security and Ease of Use” white paper, healthcare organizations (81%) expect to see a greater investment in telehealth solutions over the next 2-3 years, with 85% of decision-makers identifying “ease of use” as a top-five driver in producing good outcomes from telehealth. While many hospitals and health clinics have adopted video conferencing services during the pandemic for providing patient care, BlueJeans Telehealth was designed from the ground up for healthcare organizations to simplify the virtual join and visit experience and offer greater access to care, provide more flexibility for providers and patients, improve safety and extend the reach of services available.” 

Verizon went on to describe the service. 

“BlueJeans Telehealth delivers an intuitive experience for patients, providers and administrators. Using the device of their choice, patients can easily and quickly meet with their providers through their desktop or mobile browser or the BlueJeans app. BlueJeans with Dolby Voice Audio® provides high-quality audio, minimizing disruptions to the visit so patients and providers can communicate important clinical information clearly. Providers and administrators will also benefit from a streamlined experience, as visits are embedded directly within their existing Electronic Health Record (EHR) workflows.

To simplify administrations and reimbursements, licensing is based on a per-visit model, which allows for straightforward data capture and reporting—an important aspect considering 59% of survey respondents cited uncertainty about telehealth reimbursement as a top challenge for adoption and utilization moving forward. BlueJeans Telehealth licenses will also be available in a named host format.”

Lanton Law has been active with telehealth/telemedicine policy advocacy as well as interpreting current laws while giving clients strategic advice on potential regulatory pitfalls. 

Lanton Law is a national boutique law andlobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current telemedicine landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions,contact us today.

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Virginia on Track to Become Second Second State to Pass Data Privacy Laws

Lanton Law’s privacy practice has been closely monitoring the various state conversations around data privacy. We previously wrote a blog post titled California’s Consumer Privacy Act Could Be Coming to a State Near You, where we traced how California took the first step to create a consumer privacy law in the wake of Europe’s General Data Protection Regulation.

Lanton Law’s privacy practice has been closely monitoring the various state conversations around data privacy. We previously wrote a blog post titled California’s Consumer Privacy Act Could Be Coming to a State Near You, where we traced how California took the first step to create a consumer privacy law in the wake of Europe’s General Data Protection Regulation.    

So what’s going on with Virginia? Earlier this month the Virginia Senate passed 

 Senate Bill 1392, titled the Consumer Data Protection Act. The Virginia House of Delegates approved a companion (identical) House Bill H.B. 2307 by an 89-9 vote. Each bill likely will be heard in committee next week by the opposite chamber, which provides additional opportunities to make amendments. The state General Assembly will adjourn on March 1, it is expected that Governor Northam will sign the legislation. 

What does the bill do? The proposed legislation seeks the following:

“Establishes a framework for controlling and processing personal data in the Commonwealth. The bill applies to all persons that conduct business in the Commonwealth and either (i) control or process personal data of at least 100,000 consumers or (ii) derive over 50 percent of gross revenue from the sale of personal data and control or process personal data of at least 25,000 consumers. The bill outlines responsibilities and privacy protection standards for data controllers and processors. The bill does not apply to state or local governmental entities and contains exceptions for certain types of data and information governed by federal law. The bill grants consumer rights to access, correct, delete, obtain a copy of personal data, and to opt out of the processing of personal data for the purposes of targeted advertising. The bill provides that the Attorney General has exclusive authority to enforce violations of the law, and the Consumer Privacy Fund is created to support this effort. The bill has a delayed effective date of January 1, 2023.”

As with major policy issues that have yet to have a federal solution, states like California, Virginia and others are creating piecemeal policies, which will create compliance issues for entities that operate in several jurisdictions. New York, Oklahoma, Washington State, Minnesota, and North Dakota are jurisdictions that we continue to monitor with brewing policies on point.  

As we become more reliant on technology which crosses several sectors now, businesses are finding that they have to increase their awareness of state and federal policy in order to remain compliant. We at Lanton Law can help. Our legal and lobbying tools can help offer your organization a clear path forward to navigate what will be changing policies for healthcare, technology and clean energy stakeholders. We are a D.C. based firm with no state boundaries as we are active nationwide. Contact us today to discuss your options. 

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New York Proposing Its Own Biometric Law

The New York State legislature has introduced Assembly Bill 27, which seeks to make New York the fourth state to enact a biometric privacy law. If successful it will be the second state that will allow consumers a private right of action to see companies for improper data handling.

The New York State legislature has introduced Assembly Bill 27, which seeks to make New York the fourth state to enact a biometric privacy law. If successful it will be the second state that will allow consumers a private right of action to see companies for improper data handling. 

New York is definitely taking its cue from Illinois, as that state became the first to require businesses to collect biometric data to provide notice and obtain the owner’s written consent prior to using this information. We have written about the Illinois Information Privacy Act or (BIPA) in a previous post

The New York proposal seeks to do the following: 

Establishes the biometric privacy act; requires private entities in possession of biometric identifiers or biometric information to develop a written policy establishing a retention schedule and guidelines for permanently destroying biometric identifiers and biometric information when the initial purpose for collecting or obtaining such identifiers or information has been satisfied or within three years of the individual's last interaction with the private entity, whichever occurs first. 

New York has enacted facial recognition laws in the past. In December 2020 Governor Cuomo released a press statement where he signed A6787-D/S5140-B into law that suspended “the use of facial recognition technology and other kinds of biometric technology in schools, directing a study of whether its use is appropriate in schools and issuing recommendations. The legislation places a moratorium on schools purchasing and using biometric identifying technology until at least July 1, 2022 or until the report is completed and the State Education Commissioner authorizes its use, whichever occurs later. It applies to both public and private schools in New York State.” 

Proposed Assembly Bill 27 shows that New York will continue to press forward in this area and will likely inspire other states. If you are a biometric, Health IT/digital health or technology stakeholder, your interests will be impacted.    

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Contact us today to learn about your organization’s options to prepare for additional regulatory oversight.

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Lanton Strategies: D.C. Based Lobbying Firm with No State Boundaries

COVID-19 has changed the way that we interact in a variety of ways. One of them being the way that businesses large and small interact with the government. Gone are the days where we can meet people in person without having to worry about travel restrictions and COVID-19 protocol. What remains is that businesses still need to get their voices heard. This is where Lanton Strategies has a strategic advantage.

COVID-19 has changed the way that we interact in a variety of ways. One of them being the way that businesses large and small interact with the government. Gone are the days where we can meet people in person without having to worry about travel restrictions and COVID-19 protocol. What remains is that businesses still need to get their voices heard. This is where Lanton Strategies has a strategic advantage. 

For years our firm has made connections nationwide that have allowed us to tap our business and industry rolodex in order to get client goals realized. Our unique holistic approach enables us to lobby legislators and regulators, no matter the state. In essence we are that “digital lobbyist firm” that you need. 

If you are looking for federal or state solutions and you’re unsure how to get something done, contact Lanton Strategies; a division of Lanton Law 

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FDA Releases Artificial Intelligence/Machine Learning Action Plan

Earlier this month, the FDA released its first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.

As part of its breakthrough, the FDA pointed out some interesting aspects of its new policy area.

Earlier this month, the FDA released its first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan

As part of its breakthrough, the FDA pointed out some interesting aspects of its new policy area.

“Consistent with FDA’s longstanding commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health technologies, in April of 2019, FDA published the “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.” This paper described the FDA’s foundation for a potential approach to premarket review for artificial intelligence and machine learning-driven software modifications. The ideas delineated in the discussion paper leveraged practices from our current premarket programs and relied on the International Medical Device Regulators Forum’s risk categorization principles, the FDA’s benefit-risk framework, risk management principles described in the software modifications guidance, and the organization-based total product lifecycle approach also envisioned in the Digital Health Software Precertification (Pre-Cert) Pilot Program.

As part of this proposed framework, FDA described a “Predetermined Change Control Plan” in premarket submissions. This plan would include the types of anticipated modifications—referred to as the “SaMD Pre-Specifications”—and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients —referred to as the “Algorithm Change Protocol.” In this approach, FDA expressed an expectation for transparency and real-world performance monitoring by manufacturers that could enable FDA and manufacturers to evaluate and monitor a software product from its premarket development through postmarket performance. This framework would enable FDA to provide a reasonable assurance of safety and effectiveness while embracing the iterative improvement power of artificial intelligence and machine learning-based software as a medical device.”

Lanton Law is an innovative firm at the center of tomorrow’s legal, policy and market trends. We continue to monitor the developments of emerging sectors such as AI and give counsel to stakeholders accordingly. Contact Lanton Law to discuss your lobbying and legal strategies.    

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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.

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