FTC, DOJ and HHS Extend RFI on Private Equity Control in Health Care Markets

The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) are extending the deadline by 30 days for the public to comment on a tri-agency Request for Information (RFI) examining private-equity and other corporations’ increasing control over health care markets. The new deadline is now June 5, 2024.

At Lanton Law not only do we understand the issues, but we provide you with timely solutions to help you make informed decisions about either an acquisition target or ways to maximize value. We counsel clients by performing corporate due diligence, provide strategic advice for growth and business strategies as well as structuring and executing M&A transactions.

Contact us today to learn more

New York Proposes New Cybersecurity Regulations for State Hospitals

On November 13, the Governor unveiled new cyber regulations for state hospitals. The Governor’s FY24 budget includes $500 million in funding that health care facilities may apply to upgrade their systems in order to comply. 

According to the release which can be read here states:

“The proposed regulations aim to strengthen the protections on hospital networks and systems that are critical to providing patient care, as a complement to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule that focuses on protecting patient data and health records. Under the proposed provisions, hospitals will be required to establish a cybersecurity program and take proven steps to assess internal and external cybersecurity risks, use defensive techniques and infrastructure, implement measures to protect their information systems from unauthorized access or other malicious acts, and take actions to prevent cybersecurity events before they happen.”

Lanton Law with offices in Boston and Washington D.C. 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.

Mass General Brigham partners with Best Buy to improve acute care at home via tech

Mass General Brigham has announced an innovative partnership with Best Buy. According to the press release:

“Together, they will develop solutions to support the transformational movement of shifting healthcare to patients’ homes by improving how quality and safe care are provided with technology and clinical expertise. Their first priority is to scale and support Mass General Brigham’s Home Hospital. This technology-enabled clinical delivery model will expand access to Massachusetts residents choosing to receive acute-level hospital care in the comfort of their home. This collaboration will also help address one of the biggest challenges the healthcare industry faces today — workforce shortages.”

They also addressed the future of care at home: 

“While workforce shortages plague the healthcare industry and threaten the ability of healthcare systems, the Home Hospital experience has shown an increase in employee satisfaction through innovative hybrid practice options and a reduction of clinician burnout. As part of this relationship, Best Buy Health and Mass General Brigham will engage with and make significant investments in the community to enable the next generation of the Healthcare at Home workforce. To do this they will create equitable, academic opportunities for individuals interested in pursuing nursing, paramedic and digital technology careers by offering scholarships to students choosing the at-home setting of care as their desired professional environment. They will also work to bring care in the home to the forefront of curriculum within these industries to further support the growing home healthcare model.”

Their full press release can be found here. 

Lanton Law with offices in Boston and Washington D.C. is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. 

Contact us to learn about how either our legal or lobbying services can help you attain your goals.

What is Remote Patient Monitoring (RPM)?

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.

Prescription Digital Therapeutics Bill Introduced in Congress

The Medicaid and CHIP Access to Prescription Digital Therapeutics Act also known as S. 5238 seen here was introduced on December 12, 2022 by Senator Capito (R-WV). The bill seeks to “require the Administrator of the Centers for Medicare & Medicaid Services to provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children's Health Insurance Program.” While this bill is a step forward for digital therapeutics, questions remain about this bill such as whether this bill will get introduced in the new Congress, will this bill create more access, reduce costs and is the correct reimbursement model?

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. 

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 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.

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? 

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.

Lanton Law Interviews Famlee Founder & CEO Shelley Bailey

Ron Lanton of Lanton Law interviews Shelley Bailey of Famlee. They discuss fertility, entrepreneurship and the benefits of technology for the advancement of women's health. The interview can be heard here.

What to Know about CURES 2.0

In November 2021, U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) today introduced their bipartisan Cures 2.0 legislation. The bill which is aimed at helping patients of innovative companies within healthcare and life sciences can be viewed here.

According to Congressman Upton’s press release the bill:

• Creates an entirely new agency aimed at ending some of the world’s most difficult diseases – such as cancer, diabetes, ALS, Alzheimer’s and more. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country. 

• Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.

• Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it. 

• Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.

• Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.

• Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.

We have featured this bill in a previous November 23, 2021 blog post. We believe that this is a great opportunity if you are a manufacturer, telehealth provider or clinical trial stakeholder. CURES 2.0 is something that we have been forceasting since 2020 as a way to make our system better. 

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 life sciences practice can help stakeholders understand what’s at issue 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.

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. 

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.

Prescription Digital Therapeutics (PDTs) Legislation Introduced

The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by  Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV). 

“According to the bill’s release, it would expand Medicare coverage to include PDTs, which are software-based treatments designed to directly treat disease, 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. 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 bill sponsors released a one page fact sheet about the bill and PDTs itself.

“Prescription Digital Therapeutics (PDTs) are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. These therapies are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software.

The COVID-19 pandemic and public health emergency rapidly accelerated the pace of innovation to address some of the most pressing challenges in health care. New tools are being rapidly deployed and adopted, particularly in the case of digital health, which are increasingly being used, PDTs provide clinicians and patients with evidence-based remote treatment modalities to treat substance and opioid use disorders, mental health, diabetes and other diseases and conditions. However, there is no clear statutory benefit category to allow for Medicare and Medicaid coverage for PDTs.”

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.

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. 

“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.

Data Protection Agency (DPA) Legislation Reintroduced

U.S. Senator Gillibrand (D-NY) issued a press release announcing the Data Protection Act of 2021, which would create the DPA, an independent federal agency whose goal is to protect Americans’ data, instill privacy safeguards and work to ensure that there is transparency in data sharing practices. 

There have been some changes to this proposed legislation since last year’s version of the bill. These changes include:

• Supervision of Data Aggregators: Grants the DPA authority to review Big Tech mergers involving a large data aggregator, or any merger that proposes the transfer of personal data of 50,000 or more individuals.

• Office of Civil Rights: Establishes the DPA Office of Civil Rights to advance data justice and protect individuals from discrimination. 

• Enforcement Powers: Improves DPA enforcement powers to oversee the use of high-risk data practices and to penalize, examine, and propose remedies to the social, ethical, and economic impacts of data collection.

• Penalties and Fines: Prohibits data aggregators from committing any unlawful, unfair, deceptive, abusive, or discriminatory data practices; and allows for penalties and fines to be levied if violated, including triple penalties for violations against children.

• Defines Key Terms for Transparency: Provides Key Definitions for Privacy Harm, Data Aggregators, and High-Risk Data Practice, among other key terms.

According to the release “The DPA would be an executive agency. The director would be appointed by the president and confirmed by the Senate, serves a 5-year term, and must have knowledge of technology, protection of personal data, civil rights, and law. The agency may investigate, subpoena for testimony or documents, and issue civil investigative demands. It may prescribe rules and issue orders and guidance as is necessary to carry out federal privacy laws. The authority of state agencies and state attorneys general are preserved in the Act. The DPA would have three core missions:

1. Give Americans control and protection over their own data by authorizing the DPA to create and enforce data protection rules. 

2. Maintain the most innovative, successful tech sector in the world by ensuring fair competition within the digital marketplace. 

3. Prepare the American government for the digital age.”

Lanton Law’s technology practice has been monitoring privacy developments nationwide. If you are a banking/finance, technology or healthcare/life science 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.

Cybersecurity & FY 22 Discretionary Funding Request

The President’s request for fiscal year 2022 discretionary funding has been released. Below are a few mentions for cybersecurity:  

• To support agencies as they modernize, strengthen, and secure antiquated information systems and bolster Federal cybersecurity the discretionary equest recommends $500 million for the Technology Modernization Fund, an additional $110 million for the Cybersecurity and Infrastructure Security Agency, and $750 million as a reserve for Federal agency information technology enhancements.  

With increased hacking and ransomware attacks, cybersecurity is going to be more front and center for both policy and legal discussions. For example in this request by the Administration, the attack on SolarWinds Corp. and Microsoft Exchange’s email servers were expressly mentioned. For stakeholders that traffic in data, cybersecurity policies are essential. Ensuring compliance with federal and state requirements are key and we can help. 

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. 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. 

Verizon Enters the Telehealth Market

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.

New York Privacy Act Introduced into the New York State Legislature

A680 titled the New York Privacy Act has been introduced into the New York State Assembly. The bill is sponsored by Assemblywoman Rosenthal (D-District 67). 

The proposed bill seeks to enact the NY privacy act to require companies to disclose their methods of de-identifying personal information, to place special safeguards around data sharing and to allow consumers to obtain the names of all entities with whom their information is shared. Furthermore the proposed bill creates a special account to fund a new office of privacy and data protection.  

While the bill has echoes of Europe’s General Data Protection Regulation consent requirements, this bill takes a hard line approach on the subject which requires consent for all   processing activities and third-party disclosures, with no exceptions, the proposed bill as currently written raises significant concerns with how businesses would realistically be able to comply with the proposal’s requirements. 

Penalties are very strong under this proposal as seen below:

The attorney general may bring an action in the name of the state,or as parens patriae on behalf of persons  residing  in  the  state,  to enforce this article.

In addition to any right of action granted to any governmental body pursuant to this section, any person who has been injured by reason of a violation  of this article may bring an action in his or her own name to enjoin such unlawful act, or to recover his or her  actual  damages,  or both  such  actions. The court may award reasonable attorney's fees to a prevailing plaintiff.

Any controller or processor who violates this article is subject to an injunction and liable for damages and a civil penalty. When calculating damages and civil penalties, the court shall consider the number  of affected  individuals,  the  severity of the violation, and the size and revenues of the covered entity. Each individual  whose  information  was unlawfully  processed  counts as a separate violation. Each provision of this article that was violated counts as a separate violation.

Privacy is a hotly trending topic that is showing now signs of slowing down. Bills like this one will require significant work as it makes its way through the legislature in order for New York to achieve consumer protection while enacting a workable law that businesses will be able to comply with. 

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.  

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. 

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.

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. 

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 

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.

“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.    

Biometric Policies Will Likely Be Debated Nationwide in 2021

New York has introduced Assembly Bill 27. According to the proposed bill, AB 27 seeks “to establish 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.”  

Currently, the Illinois Biometric Information Privacy Act, commonly known as BIPA, is the only state with a biometric privacy statute that provides for a similar private right of action. We have been writing in previous posts about how state policies have been taking shape regarding this subject. 

We expect this and other technology questions to be debated in various state houses throughout 2021. It is imperative for interested stakeholders to be prepared for what new potential legislation requires. Contact Lanton Law to discuss your lobbying and legal strategies.   

New Telehealth Legislation Introduced In the U.S. House of Representatives

Lanton Law has been monitoring the state and federal policy developments with telehealth/telemedicine. We have noticed a newly introduced Congressional bill that is on point. 

The Protecting Access to Post-Covid-19 Telehealth Act has been introduced by several members of the Congressional Telehealth Caucus including Representatives Schweikert (R-AZ), Thompson (D-CA), Welch (D-VT), Johnson (R-OH) and Matsui (D-CA). 

This bi-partisan bill according to the bill’s press release “will continue the expanded use of telehealth beyond the Coronavirus pandemic by eliminating restrictions on the use in Medicare, providing a bridge for patients currently using the practices because of the crisis, and requiring a study on the use of telehealth during COVID-19.”  

Here are the highlights of the legislation according to the release: 

• Eliminating most geographic and originating site restrictions on the use of telehealth in Medicare and establishing the patient’s home as an eligible distant site so patients can receive telehealth care at home and doctors can still be reimbursed, 

• Preventing a sudden loss of telehealth services for Medicare beneficiaries by authorizing the Centers for Medicare and Medicaid Service to continue reimbursement for telehealth for 90 days beyond the end of the public health emergency, 

• Making permanent the disaster waiver authority, enabling Health and Human Service to expand telehealth in Medicare during all future emergencies and disasters, and

• Requiring a study on the use of telehealth during COVID, including its costs, uptake rates, measurable health outcomes, and racial and geographic disparities.

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, 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.