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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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. 

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.

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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.

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.

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President Biden Signs Executive Order to Regulate U.S. Investments in Sensitive Technologies in Countries of Concern

President Biden signed an executive order on August 9, 2023, that will regulate certain U.S. investments in countries of concern in entities engaged in activities involving sensitive technologies critical to national security. The order specifically targets investments in semiconductors and microelectronics, quantum information technologies, and artificial intelligence.

President Biden signed an executive order on August 9, 2023, that will regulate certain U.S. investments in countries of concern in entities engaged in activities involving sensitive technologies critical to national security. The order specifically targets investments in semiconductors and microelectronics, quantum information technologies, and artificial intelligence.

The order identifies the People's Republic of China (PRC) as a country of concern and requires the Secretary of the Treasury develop a program to regulate U.S. investments in these sensitive technologies in countries of concern. The program will prohibit certain investments in entities that engage in specific activities related to these technology areas that pose the most acute national security risks, and require notification for other sensitive investments.

The order is designed to prevent foreign countries of concern from exploiting U.S. investment in these sensitive technologies to develop military, intelligence, surveillance, and cyber-enabled capabilities that risk U.S. national security.

If you are a technology company and you are concerned about how to navigate an evolving regulatory environment, contact Lanton Law today. We stay up-to-date on the latest technology policy and legal trends and can help you implement new business strategies.

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Tech Firms Sign White House AI Pledge Over Concerns of Potential AI Risks

This week the Biden Administration secured voluntary commitments from seven leading artificial intelligence (AI) companies, including Amazon, Anthropic, Google, Inflection, Meta, Microsoft, and OpenAI, to promote the safe, secure, and transparent development of AI technology.

This week the Biden Administration secured voluntary commitments from seven leading artificial intelligence (AI) companies, including Amazon, Anthropic, Google, Inflection, Meta, Microsoft, and OpenAI, to promote the safe, secure, and transparent development of AI technology. These commitments focus on three fundamental principles: safety, security, and trust. The companies pledge to conduct internal and external security testing of their AI systems before release, share information on managing AI risks with various stakeholders, and invest in cybersecurity measures. They also commit to ensuring users can identify AI-generated content, publicly report on AI capabilities and limitations, prioritize research on societal risks like bias and discrimination, and develop AI systems to address significant challenges such as cancer prevention and climate change.

The Biden Administration will continue its efforts to establish an international framework for AI governance and has already consulted with numerous countries on the voluntary commitments. The administration aims to ensure AI development is conducted safely and responsibly to protect Americans from harm and discrimination. Prior actions include convening industry leaders to discuss AI risks, signing an Executive Order to address bias in technology, and investing in AI research and development institutes across the country. The administration is also preparing policy guidance for federal agencies to ensure AI systems prioritize the protection of citizens' rights and safety.

Artificial Intelligence is clearly an emerging 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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California Privacy Regulator Releases Draft Regulations

The California Privacy Protection Agency, the regulator established by the California Privacy Rights Act in November 2020 has posted draft regulations for its upcoming June 8 Board meeting. The draft CPRA regulations can be viewed here.

The California Privacy Protection Agency, the regulator established by the California Privacy Rights Act in November 2020 has posted draft regulations for its upcoming June 8 Board meeting. The draft CPRA regulations can be viewed here

The draft regulations do need work to clarify several issues. The draft does address privacy notice requirements, as well as how companies must notify its contractors and vendors to delete personal information as well as how to respond to opt out preference signals. The rules are forecasted to take effect on January 1, 2023. 

Lanton Law is a national healthcare & technology law and government affairs firm. Our technology practice has been monitoring privacy developments nationwide. If you are a commerce, 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.

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Comprehensive national data privacy and data security draft legislation framework released

The U.S. House Committee on Energy and Commerce has introduced a bi-partisan discussion framework on privacy.

According to the U.S. House Committee on Energy and Commerce:

“U.S. Representatives Frank Pallone, Jr., D-N.J. and Cathy McMorris Rodgers, R-Wash., Chairman and Ranking Member of the House Committee on Energy and Commerce, and U.S. Senator Roger Wicker, R-Miss., Ranking Member of the Senate Committee on Commerce, Science, and Transportation, today released a discussion draft of a comprehensive national data privacy and data security framework. The draft legislation is the first comprehensive privacy proposal to gain bipartisan, bicameral support.”  

What does the American Data Privacy and Protection Act do?

  • Establish a strong national framework to protect consumer data privacy and security;

  • Grant broad protections for Americans against the discriminatory use of their data;

  • Require covered entities to minimize on the front end, individuals’ data they need to collect, process, and transfer so that the use of consumer data is limited to what is reasonably necessary, proportionate, and limited for specific products and services;

  • Require covered entities to comply with loyalty duties with respect to specific practices while ensuring consumers don’t have to pay for privacy;

  • Require covered entities to allow consumers to turn off targeted advertisements;

  • Provide enhanced data protections for children and minors, including what they might agree to with or without parental approval; 

  • Establish regulatory parity across the internet ecosystem; and

  • Promote innovation and preserve the opportunity for start-ups and small businesses to grow and compete.

The discussion draft can be found here.

Lanton Law is a national healthcare & technology law and government affairs firm. Our technology practice has been monitoring privacy developments nationwide. If you are a commerce, 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.

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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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Lanton Law Podcast Episode 1

On Episode 1 Lanton Law speaks with STACK CEO Jonathan Ogurchak about privacy trends, healthcare efficiencies using SAAS and whether healthcare is ready for tech disruption.

On Episode 1 Lanton Law speaks with STACK CEO Jonathan Ogurchak about privacy trends, healthcare efficiencies using SAAS and whether healthcare is ready for tech disruption. Click here to listen to the podcast.

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FDA Releases Draft Cybersecurity Guidance

The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.”

The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” The draft guidance can be viewed here. Comments are due July 7, 2022. 

What is the FDA proposing? 

In 2018, the FDA proposed updates to the final guidance, ‘‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,’’ and issued a draft guidance of the same name.”

This draft guidance replaces the aforementioned 2018 guidance and is “intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns.” 

Why is the FDA doing this? 

According to the draft guidance as “more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system.”

How Lanton Law can help

Society’s reliance on technology has become even more vital with the effects of COVID-19. With all of the hacking and malware attacks we have witnessed against various data stakeholders, we foresee cybersecurity as a major legal & policy area that will continue to be expanded.   

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. If you are a tech or healthIT 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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The Platform Accountability and Transparency Act (PATA) Introduced to Ensure Social Media Platform Transparency

Senators Coons (D-DE), Kloubuchar (D-MN) and Portman (R-OH) have introduced a bi-partisan proposed bill that would require social media companies to provide vetted, independent researchers and the public with access to certain platform data.

Senators Coons (D-DE), Kloubuchar (D-MN) and Portman (R-OH) have introduced a bi-partisan proposed bill that would require social media companies to provide vetted, independent researchers and the public with access to certain platform data.

According to the bill’s press release, PATA proposes the following:

  • Under PATA, independent researchers would be able to submit proposals to the National Science Foundation, an independent agency designed to promote the progress of science by approving research and development proposals from researchers across the sciences. If the requests are approved, social media companies would be required to provide the necessary data subject to certain privacy protections.

    • Companies that failed to comply would be subject to enforcement from the Federal Trade Commission (FTC) and face the potential loss of immunity under Section 230 of the Communications Decency Act.  

  • Additionally, the bill would give the FTC the authority to require that platforms proactively make certain information available to researchers or the public on an ongoing basis, such as a comprehensive ad library with information about user targeting and engagement.

  • The proposal would also protect researchers from legal liability that may arise from automatically collecting platform information if they comply with various privacy safeguards.  

The bill can be viewed here

This bill is important to watch as part of an ongoing trend of increasing policy scrutiny on the tech sector.

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. Our technology practice monitors relevant policy and regulatory decision makers and we counsel clients on emerging trends within this rapidly developing field. 

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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Rohit Chopra of the Consumer Financial Protection Bureau testified before the House Financial Services Committee on Changing Tech Stakeholder Influence

Rohit Chopra who is the Director of the Consumer Financial Protection Bureau testified before the House Financial Services Committee regarding how “Congress has tasked the CFPB with monitoring market conditions to spot risks, ensure compliance with existing law, and promote competition in order to protect families and honest businesses.”

Rohit Chopra who is the Director of the Consumer Financial Protection Bureau testified before the House Financial Services Committee regarding how “Congress has tasked the CFPB with monitoring market conditions to spot risks, ensure compliance with existing law, and promote competition in order to protect families and honest businesses.”

He outlined the Bureau’s concerns with today’s tech and fintech market influences. 

“Technological progress holds the potential for enormous benefits to households and the economy, particularly with respect to real-time consumer payments. At the same time, the desire of Big Tech to gain greater control over the flow of money in the economy raises a number of questions. For example, how will these firms harvest 2 and monetize data they collect on our transactions? What criteria will they use to decide who is removed from the platform? How will they ensure that payment systems adhere to consumer protections? Will Big Tech giants have an incentive to impede the entry of new firms seeking to offer competitive products and services? With this in mind, the CFPB has issued orders to dominant firms such as Facebook, Google, Apple, Amazon, Square, and PayPal to shed light on some of these questions. We will also be studying some of the practices of Chinese tech giants, including services provided by WeChat Pay and AliPay. These efforts complement other work within the Federal Reserve System to ensure families and businesses can rely on a fast and reliable payments system. It will also inform other initiatives to ensure that our evolving payments landscape is in alignment with our national interest. Given the state of today’s economic conditions, the Bureau also intends to ramp up its monitoring of other markets and their impact on specific population segments.”

Mr. Chopra’s testimony can be viewed here. Throughout the year we have seen where the fintech and technology stakeholder interests have begun to merge due to a changing marketplace. 

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. 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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First Meeting of the President’s Council of Advisors on Science and Technology Occurs

The White House held the first meeting of the President’s Council of Advisors on Science and Technology Occurs (PCAST). PCAST deals with “1) U.S. competitiveness, security, and international science and technology leadership; and 2) U.S. public health and pandemic preparedness.”

The White House held the first meeting of the President’s Council of Advisors on Science and Technology (PCAST). PCAST deals with “1) U.S. competitiveness, security, and international science and technology leadership; and 2) U.S. public health and pandemic preparedness.” 

“PCAST focused its meeting on two topics: U.S. competitiveness, security, and international science and technology leadership; and U.S. public health and pandemic preparedness. The meeting provided PCAST with an opportunity to hear from representatives of a broad range of sectors, including federal, state, and local governments, academia, and industry.”

Additional details on this meeting can be found here

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on technology and healthcare/life science. We continue to monitor the policy and legal developments around the FTC.

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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FTC Report to Congress on Privacy and Security

The Federal Trade Commission (FTC) last month issued the FTC Report to Congress on Privacy and Security.

The Federal Trade Commission (FTC) last month issued the FTC Report to Congress on Privacy and Security

What’s in the Report? 

According to the agency “This report responds to the Joint Explanatory Statement accompanying the Consolidated Appropriations Act, 2021, P.L. 116-260, directing the Federal Trade Commission (“Commission” or “FTC”) to “conduct a comprehensive internal assessment measuring the agency’s current efforts related to data privacy and security while separately identifying all resource-based needs of the FTC to improve in these areas. The agreement also urges the FTC to provide a report describing the assessment’s findings to the Committees [on Appropriations of the House and Senate] within 180 days of enactment of this Act.”

Additionally, “The report first provides an overview of the FTC’s authority related to privacy and security, highlighting certain recent efforts in those areas. Second, it discusses priorities for improving the effectiveness of our efforts to protect Americans’ privacy. Third, it identifies areas in which we could use additional resources to further ensure Americans’ privacy is protected. Finally, it discusses the need for Congressional action on the FTC’s authority.”

Lanton Law is a national boutique regulatory law and lobbying firm that focuses on healthcare/life science and technology. We continue to monitor the policy and legal developments around the FTC.

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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New Request for Public Comment Regarding Technology Stakeholders

The Bureau of Industry and Security, Office of Technology Evaluation, U.S. Department of Commerce has issued a Notice of request for public comment. The notice is titled Notice of Request for Public Comments. According to the Bureau:

The Bureau of Industry and Security, Office of Technology Evaluation, U.S. Department of Commerce has issued a Notice of request for public comment. The notice is titled Notice of Request for Public Comments. According to the Bureau: 

On February 24, 2021, President Biden issued Executive Order 14017 (E.O. 14017) on “America's Supply Chains,” which directs several federal agency actions to secure and strengthen America's supply chains. One of these directions is for the Secretary of Commerce and the Secretary of Homeland Security, in consultation with the heads of appropriate agencies, to submit, within one year of the date of E.O. 14017, a report on supply chains for critical sectors and subsectors of the information and communications technology (ICT) industrial base (as determined by the Secretary of Commerce and the Secretary of Homeland Security), including the industrial base for the development of ICT software, data, and associated services. This notice requests comments and information from the public to assist the Secretary of Commerce and the Secretary of Homeland Security in preparing the report required by E.O. 14017.

The comment deadline is November 4, 2021. 

Lanton Law’s technology practice has been monitoring similar legislative and legal developments. If you are a 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.

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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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U.S. Senate Passes the Innovation and Competition Act

Earlier this month the U.S. Senate passed a rare bi-partisan bill called the United States Innovation and Competition Act, which seeks to improve America's competitive edge by investing billions of dollars in scientific and technological innovations – including artificial intelligence, computer chips and robotics.

Earlier this month the U.S. Senate passed a rare bi-partisan bill called the United States Innovation and Competition Act, which seeks to improve America's competitive edge by investing billions of dollars in scientific and technological innovations – including artificial intelligence, computer chips and robotics. The bill would boost funding for research and technology manufacturing to increase America's competitiveness, strengthen national security and grow the economy. The bill’s future is uncertain in the U.S. House of Representatives, where the House has a similar bill but it is unlikely that there will not be some kind of compromise between the House and Senate, especially where national security is concerned. 

Lanton Law’s technology practice has been monitoring similar legislative and legal developments. If you are a 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.  

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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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White House Releases Report Outlining Steps to Strengthen Critical Supply Chains

In February 2021, President Biden issued an Executive Order to direct a government-wide “approach to assessing vulnerabilities in, and strengthening the resilience of, critical supply chains.”

In February 2021, President Biden issued an Executive Order to direct a government-wide “approach to assessing vulnerabilities in, and strengthening the resilience of, critical supply chains.” 

The key findings highlight recommendations from its “comprehensive 100-day supply chain assessments for four critical products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).” 

Lanton Law has several years of experience with supply chain issues. Our firm 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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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.

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.

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