Ron Lanton 8/12/23 Ron Lanton 8/12/23

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.

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.

Ron Lanton 7/27/23 Ron Lanton 7/27/23

Privacy & Technology Companies: Why You May Need an Attorney

Technology companies are constantly collecting and using personal data. This data can include everything from names and addresses to browsing history and financial information. As technology companies collect more data, the importance of privacy becomes even more critical.

There are a number of reasons why technology companies need a lawyer to help them with privacy. First, lawyers can help companies understand the laws that apply to them. These laws can vary depending on the country or region where the company operates.

Second, lawyers can help companies develop and implement relevant policies and procedures. These policies and procedures should be designed to protect the company's users.

Third, lawyers can help companies respond to privacy inquiries and complaints. If a user has a question or complaint about a company's privacy practices, the company needs to be able to respond promptly and effectively.

Privacy is a complex issue, and technology companies need to take it seriously. By working with a lawyer, technology companies can ensure that they are compliant with the law and that they are protecting the privacy of their users.

Ron Lanton 7/27/23 Ron Lanton 7/27/23

H.R. 3831: The AI Disclosure Act of 2023 Explained

H.R. 3831, the AI Disclosure Act of 2023, is a bill that would require companies that use artificial intelligence (AI) to disclose certain information about their use of AI. This information would include the purpose of the AI system, the data that the AI system is trained on, the algorithms that the AI system uses, and the potential risks and benefits of the AI system. The bill would also create a new agency within the Federal Trade Commission (FTC) to oversee the implementation of the law.

This bill is important because it would increase transparency and accountability in the use of AI. By requiring companies to disclose information about their use of AI, the bill would help consumers to understand how AI is being used and to make informed decisions about whether to use AI-powered products and services.

It is still too early to say whether H.R. 3831 will become law. However, the bill has generated a lot of interest and debate, and it is likely to continue to be a topic of discussion in the coming months.

If you are a stakeholder in the AI industry, you should be aware of H.R. 3831 and its potential implications for your business. Lanton Law’s technology section can help you to understand the bill and to help you develop a strategy to comply with looming regulatory oversight.

Contact Lanton Law today to learn more about how we can help you with your AI legal and policy needs.

Ron Lanton 7/23/23 Ron Lanton 7/23/23

More Drugmakers Sue Biden Administration Over Medicare Negotiation

Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violates the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.

Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violate the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.

As part of the new law, the Centers for Medicare and Medicaid Services (CMS) will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.

Lanton Law 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.

Ron Lanton 7/21/23 Ron Lanton 7/21/23

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. 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.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Privacy Trends in New York: How Lanton Law Can Assist Tech and Healthcare Companies with Legal and Regulatory Strategies

Privacy has emerged as a critical issue in the digital age, prompting increased scrutiny and regulation. In New York, a hub for technology and healthcare industries, privacy trends have been shaping the legal and regulatory landscape. This blog post will explore the evolving privacy trends in New York and delve into how Lanton Law can help tech and healthcare companies navigate complex privacy laws and develop effective legal and regulatory strategies.

New York has been proactive in addressing privacy concerns, recognizing the importance of protecting personal information in an increasingly interconnected world. Several key privacy laws and regulations have been enacted, creating a robust privacy framework for businesses operating in the state.

The New York Privacy Act, if passed, would establish comprehensive privacy rights for consumers, similar to the European Union's General Data Protection Regulation (GDPR). It would empower individuals with control over their personal data and impose stringent obligations on businesses regarding data protection and transparency.

Additionally, the Stop Hacks and Improve Electronic Data Security (SHIELD) Act has enhanced data breach notification requirements and expanded the definition of personal information. It mandates businesses to implement reasonable security measures and imposes penalties for non-compliance.

Lanton Law has an emerging privacy and data protection section. Here's how our firm can help:

a. Compliance Assessment: We can conduct comprehensive privacy assessments to identify areas of non-compliance and help businesses align their practices with applicable state and federal privacy regulations. We can review your policies, procedures, and data handling practices to ensure adherence to legal requirements.

b. Privacy Policy Development: We can assist in drafting and updating privacy policies that meet the specific needs of your industry. These policies often outline data collection practices, disclosure mechanisms, and individual rights, providing transparency and legal compliance.

c. Consent Mechanisms: With the increasing emphasis on consent, Lanton Law can help companies develop effective mechanisms for obtaining and managing consent. This includes ensuring clear and informed consent practices, implementing opt-in and opt-out mechanisms, and maintaining records of consent.

d. Privacy Impact Assessments: Lanton Law can conduct Privacy Impact Assessments (PIAs) to identify privacy risks associated with the implementation of new technologies, data-sharing practices, or changes in business operations. PIAs help companies proactively address privacy concerns and mitigate risks.

e. Dispute Resolution: In case of privacy-related disputes, Lanton Law can provide strategic guidance.

Conclusion:

As privacy concerns continue to grow in the digital age, New York has been at the forefront of enacting comprehensive privacy legislation. Tech and healthcare companies in the state must adapt to these evolving trends to protect consumer data and maintain compliance with privacy regulations.

Lanton Law's experience in privacy and data protection enables these companies to navigate the complex legal and regulatory landscape effectively. By partnering with us, tech and healthcare organizations can develop robust strategies, ensuring compliance, safeguarding personal data, and maintaining trust among your consumers.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Unleashing the Power of Lanton Law: The Key to Effective Lobbying

When it comes to navigating the complex world of lobbying, choosing the right lobbyist will make all the difference. Lanton Law offers a unique approach that has proven to be highly effective in driving positive change.

One of the primary reasons for choosing us is the wealth of experience and expertise that our team brings to the table. From policy analysis and strategic planning to coalition building and stakeholder engagement, our approach ensures that our clients' interests are well represented and advocated for.

Leveraging our extensive network and deep industry connections, we develop tailored strategies that align with our clients' specific goals and priorities. Our personalized approach results in more effective and tangible results.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Lanton Law Quoted in Pharmacy Times Article Titled "Mifepristone Has its Day in Court"

Lanton Law was quoted in Pharmacy Times article titled “Mifepristone Has its Day in Court.” The article discusses the drug amid its backdrop in the U.S. Supreme Court.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Lanton Law Lobbies on Beacon Hill in Boston, Massachusetts for Pharmacy Issues

Lanton Law was on Beacon Hill this week advocating for pharmacy issues.

Lanton Law was on Beacon Hill this week advocating for pharmacy issues. We are happy to be working with several pharmacy allies within the legislature on meaningful issues around health promotion screening and pharmacy benefit manager transparency.

Ron Lanton 7/14/23 Ron Lanton 7/14/23

Lanton Law Quoted in Pharmacy Times Article "FDA Approves First Nonprescription Daily Birth Control Pill"

Lanton Law was quoted in the Pharmacy Times article titled “FDA Approves First Nonprescription Daily Birth Control Pill.”

Lanton Law was quoted in the Pharmacy Times article titled “FDA Approves First Nonprescription Daily Birth Control Pill.” The article can be viewed here.

Ron Lanton 5/9/23 Ron Lanton 5/9/23

Latest Mifepristone Legal Debates Raise More Questions, Confusion for Health Care Professionals

Lanton Law speak with Pharmacy Times about the Supreme Court’s decision on Mifepristone.

Lanton Law speak with Pharmacy Times about the Supreme Court’s decision on Mifepristone. Click here for the interview.

Ron Lanton 4/27/23 Ron Lanton 4/27/23

Lanton Law Teams Up With MSHP on Health Promotion Screening Bill

On behalf of the Massachusetts Society of Health-System Pharmacists, we wrote an article advocating for the importance of health promotion screening in Massachusetts.

On behalf of the Massachusetts Society of Health-System Pharmacists, we wrote an article advocating for the importance of health promotion screening in Massachusetts. The Pharmacy Times article can be accessed here.

Ron Lanton 4/27/23 Ron Lanton 4/27/23

Lanton Law Speaks at Summit & Reverse Expo

We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.

Ron Lanton 3/3/23 Ron Lanton 3/3/23

Congressional Bill Advocating for Biosimilars and Generics Introduced

U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) have introduced the Affordable Prescriptions for Patients Act. The bill seen here seeks to lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market. The bill addresses two important issues such as product hopping and the patent dance.

Product hopping: As far as product hopping, “the bill puts an end to this practice. It prohibits branded drug manufacturers from engaging in anticompetitive product hopping and facilitates entry to the market for generics and biosimilars, driving down drug costs.”

Patent dance: “This bill places a reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket.” This will help deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place.”

Ron Lanton 2/27/23 Ron Lanton 2/27/23

DEA Announces Proposed Rules for Telemedicine

The Drug Enforcement Administration has announced “proposed permanent rules for the prescribing of controlled medications via telemedicine, expanding patient access to critical therapies beyond the scheduled end of the COVID-19 public health emergency.

Additionally, the “proposed rules would provide safeguards for a narrow subset of telemedicine consultations—those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a controlled medication. For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe:

a 30-day supply of Schedule III-V non-narcotic controlled medications;
a 30-day supply of buprenorphine for the treatment of opioid use disorder

without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. The proposed rules are explained in further detail for patients and medical practitioners on DEA.gov.”

The proposed rule can be found here.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our firm helps various stakeholders with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help entities nationwide grow business opportunities through carefully crafted legislation.

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.

Ron Lanton 2/27/23 Ron Lanton 2/27/23

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)?

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.

Ron Lanton 1/12/23 Ron Lanton 1/12/23

FDA REMS Change for Abortion Pill Creates Opportunities, Questions for Pharmacists

Although the FDA has now allowed retail pharmacies to dispense mifepristone, a drug used for medicated abortions, questions still remain about the requirements for pharmacies and the availability of the drug. Lanton Law talks to Pharmacy Times in an interview about a post Dobbs world with mifepristone.

Ron Lanton 12/27/22 Ron Lanton 12/27/22

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 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.

Ron Lanton 10/18/22 Ron Lanton 10/18/22

Lanton Law Talks Provider Status With Don Downing; Clinical Professor at the UW School of Pharmacy

We have a new podcast with Professor Downing of the University of Washington School of Pharmacy. We discuss pharmacy provider status and the opportunities within pharmacy.

We have a new podcast with Professor Downing of the University of Washington School of Pharmacy. We discuss pharmacy provider status and the opportunities within pharmacy. Listen here.

Ron Lanton 8/8/22 Ron Lanton 8/8/22

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.

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.