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.
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.
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.
House Lawmakers Release Anti-Monopoly Agenda for “A Stronger Online Economy: Opportunity, Innovation, Choice”
According to press release, the House Committee on the Judiciary’s Antitrust Subcommittee Chairman Cicilline (D-RI) and Ranking Member Buck (R-CO) announced their antitrust bi-partisan agenda outlined below:
According to press release, the House Committee on the Judiciary’s Antitrust Subcommittee Chairman Cicilline (D-RI) and Ranking Member Buck (R-CO) announced their antitrust bi-partisan agenda outlined below:
“‘A Stronger Online Economy: Opportunity, Innovation, Choice’ consists of five bipartisan bills drafted by lawmakers on the Antitrust Subcommittee, which last year completed a 16-month investigation into the state of competition in the digital marketplace and the unregulated power wielded by Amazon, Apple, Facebook, and Google.”
The “American Innovation and Choice Online Act” to prohibit discriminatory conduct by dominant platforms, including a ban on self-preferencing and picking winners and losers online. The bill is sponsored by Chairman Cicilline and co-sponsored by U.S. Rep. Lance Gooden (TX-05).
The “Platform Competition and Opportunity Act” prohibits acquisitions of competitive threats by dominant platforms, as well as acquisitions that expand or entrench the market power of online platforms. The bill is sponsored by U.S. Rep. Hakeem Jeffries (NY-08) and co-sponsored by Ranking Member Buck.
The “Ending Platform Monopolies Act” eliminates the ability of dominant platforms to leverage their control over multiple business lines to self-preference and disadvantage competitors in ways that undermine free and fair competition. The bill is sponsored by U.S. Rep. Pramila Jayapal (WA-07) and co-sponsored by U.S. Rep. Lance Gooden (TX-05).
The “Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act” promotes competition online by lowering barriers to entry and switching costs for businesses and consumers through interoperability and data portability requirements. This bill is sponsored by U.S. Rep. Mary Gay Scanlon (PA-05) and co-sponsored by U.S. Rep. Burgess Owens (UT-04).
The “Merger Filing Fee Modernization Act” updates filing fees for mergers for the first time in two decades to ensure that the Department of Justice and Federal Trade Commission have the resources they need to aggressively enforce the antitrust laws. This bill is sponsored by U.S. Rep. Joe Neguse (CO-02) and co-sponsored by U.S. Rep. Victoria Spartz (IN-05).
Lanton Law has been monitoring both Congress and the FTC for our technology and healthcare clients, especially as both Congress and the FTC have taken a more aggressive tone on antitrust issues lately.
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.
Lina Khan Sworn in as FTC Chair
The Federal Trade Commission (FTC) released a June 15th press release announcing Lina Khan as the Chair of the FTC, with her term expiring on September 25, 2024. Ms. Khan was confirmed by the U.S. Senate on June 15, 2021.
The Federal Trade Commission (FTC) released a June 15th press release announcing Lina Khan as the Chair of the FTC, with her term expiring on September 25, 2024. Ms. Khan was confirmed by the U.S. Senate on June 15, 2021.
Lanton Law has been monitoring the FTC for our technology and healthcare clients. This move may signal that the Biden Administration and Congress may take on a more aggressive role in antitrust policy. Technology stakeholders should take note.
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.
New Proposed Congressional DIR Relief Bill
At Lanton Law we are constantly on the watch for issues impacting our specialty, retail and LTC pharmacy clients including the issue of DIR fees. Clients utilize our advocacy and legal tools while discussing business strategy to combat an ever changing reimbursement environment.
At Lanton Law we are constantly on the watch for issues impacting our specialty, retail and LTC pharmacy clients including the issue of DIR fees. Clients utilize our advocacy and legal tools while discussing business strategy to combat an ever changing reimbursement environment.
A bipartisan group of Congressional legislators have introduced the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, also known as S. 1909/H.R. 3554. Both companion bills propose to transfer all pharmacy DIR to the point of sale. As many in the industry know, DIR fees were intended to be applied here but the definition and application of DIR fees have been so convoluted that they are causing deep and long lasting damage to the pharmacy community.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying section helps pharmacies nationwide achieve improved business climates 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.
Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access
U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.
U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.
According to Senator Cornyn’s press release “this legislation would direct HHS to establish a shared savings demonstration project to increase access to biosimilars in the Medicare program. This would encourage physicians to prescribe less-expensive biosimilars increasing patient access to more affordable, life-saving drugs and lowering patient out-of-pocket costs.
Under the demonstration, Medicare would provide an additional payment to providers for using lower-cost biosimilar products that reflects the savings created in contrast to administering the higher-cost reference biological product. Additionally, Medicare can use a portion of those savings to reduce the beneficiary’s coinsurance payment.”
Lanton Law is a national boutique 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.
NCPA Files Lawsuit on Pharmacy Direct & Indirect Remuneration (DIR) Fees
The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:
The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:
The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.
The rule is invalid as arbitrary and capricious. In 2014 CMS said that the “reasonably determined” exception leading to DIR fees would be “narrow,” but comment letters showed that not to be the case.3 A recent study showed that pharmacy DIR fees have increased 1600% since 2015, with $4 billion in DIR fees being squeezed from pharmacies in 2017 alone.
The Final Rule Was Not Adopted Through Proper Notice-and-Comment Rulemaking. The proposed rule defined negotiated prices to include all price concessions from pharmacies and did not discuss or address any exceptions. In the final rule, without giving interested parties notice or the opportunity to comment, CMS created the exception for price concessions that could not be reasonably determined at the point of sale.
HHS did file a motion to dismiss available here.
Lanton Law will continue to monitor the developments of this important case.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying entity (Lanton Strategies) is helping pharmacies nationwide achieve improved business climates 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.
Biden Administration Files Motion Supporting Canadian Drug Imports
The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada.
The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada. This motion is aimed at prior enacted state legislation from both Florida and New Mexico, as both states have commenced the process of applying for Canadian imports. The Administration argues in its brief that the party opponent’s (Pharmaceutical Research & Manufacturers of America PhRMA) claim is not prudentially ripe.
Importation is an issue that Lanton Law has been monitoring for several years. As the drug pricing debate continues across Congress and state legislatures, we fully anticipate importation to continue to be a front and center policy issue.
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.
Update on FTC Administrative Complaint Against Illumina
Lanton Law has been monitoring the developments around the FTC’s administrative complaint against Illumina on marketplace competition concerns. We have recently shared an industry blog about this issue.
Lanton Law has been monitoring the developments around the FTC’s administrative complaint against Illumina on marketplace competition concerns. We have recently shared an industry blog about this issue.
As an update to this matter, the FTC has issued a press release that explained the agency’s Motion to Dismiss for Preliminary Relief in Illumina/GRAIL Case. According to the FTC, “In the wake of the European Commission’s announcement that it is investigating Illumina’s $7.1 billion proposed acquisition of DNA sequencing provider Illumina, the Federal Trade Commission has authorized staff to dismiss its federal court complaint for Preliminary Injunction and Temporary Restraining Order.”
Additionally, ““The FTC sought preliminary relief in federal court to prevent Illumina and GRAIL from merging while the case is being decided on the merits in administrative court. At the time, a district court order was necessary to prevent the parties from consummating their merger. The administrative trial is scheduled to begin on August 24, 2021. Now that the European Commission is investigating, Illumina and GRAIL cannot implement the transaction without obtaining clearance from the European Commission.”
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.
New Bi-Partisan Privacy Bill Introduced
The Social Media Privacy Protection and Consumer Rights Act of 2021 has been reintroduced and is being led by Senators Kennedy (R-LA), Klobuchar (D-MN), Manchin (D-WV and Burr (R-NC). The proposal seeks to improve the transparency of online platforms, strengthen consumers’ options when a data breach occurs and ensure companies comply with privacy policies that protect consumers.
The Social Media Privacy Protection and Consumer Rights Act of 2021 has been reintroduced and is being led by Senators Kennedy (R-LA), Klobuchar (D-MN), Manchin (D-WV and Burr (R-NC). The proposal seeks to improve the transparency of online platforms, strengthen consumers’ options when a data breach occurs and ensure companies comply with privacy policies that protect consumers.
According to the bill’s press release the proposal seeks the following:
Give consumers the right to opt out and keep their information private by disabling data tracking and collection,
Provide users greater access to and control over their data,
Require terms of service agreements to be in plain language,
Ensure users have the ability to see what information about them has already been collected and shared,
Mandate that users be notified of a breach of their information within 72 hours,
Offer remedies for users when a breach occurs, and
Require that online platforms have a privacy program in place.
Lanton Law’s technology practice has been monitoring privacy developments nationwide. 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.
New Executive Order on Cybersecurity Released in Response to Ransomware Attack
In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity.
In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity. The EO has a number of provisions including:
Establishes a “Cybersecurity Safety Review Board” comprising public- and private-sector officials, which can convene after cyber attacks to analyze the situation and make recommendations.
Requires IT service providers to tell the government about cybersecurity breaches that could impact U.S. networks, and removes certain contractual barriers that might stop providers from flagging breaches.
Plans for enhancing software supply chain security
This comes amid an increase in cyber attacks on private healthcare and technology companies as well as the federal government.
Ransomware attacks are becoming a bigger threat and being prepared from a compliance and risk management standpoint is becoming more crucial. Having appropriate cyber policies in place is one step. We have other solutions.
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.
Florida Proposed Privacy Bill Fails
H.B. 969 titled Consumer Data Privacy has failed to become the nation’s third comprehensive consumer privacy law.
H.B. 969 titled Consumer Data Privacy has failed to become the nation’s third comprehensive consumer privacy law. The legislature adjourned without reaching a legislature agreement between the House and Senate as the Senate voted 29-11 to send the bill back to the House. The main controversy around this bill not being able to advance is centered on whether a consumer should have a private right of action to sue a company for an alleged violation.
Lanton Law’s technology practice has been monitoring privacy developments nationwide. 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.
Tech Stakeholders Alert: FTC Workshop on Dark Patterns
The Federal Trade Commission (FTC) has announced an April 29, 2021 virtual workshop to examine digital “dark patterns,” a term that has been used to describe a range of potentially manipulative user interface designs used on websites and mobile apps.
The Federal Trade Commission (FTC) announced an April 29, 2021 virtual workshop to examine digital “dark patterns,” a term that has been used to describe a range of potentially manipulative user interface designs used on websites and mobile apps.
“Bringing Dark Patterns to Light: An FTC Workshop” will explore the ways in which user interfaces can have the effect, intentionally or unintentionally, of obscuring, subverting, or impairing consumer autonomy, decision-making, or choice. For example, some sites sneak extra items into a consumer’s online shopping cart, or require users to navigate a maze of screens and confusing questions to avoid being charged for unwanted products or services.
Some of the topics the workshop will examine include:
how dark patterns differ from sales tactics employed by brick-and-mortar stores;
how they affect consumer behavior, including potential harms;
whether some groups of consumers are unfairly targeted or are especially vulnerable;
what laws, rules, and norms regulate the use of dark patterns; and
whether additional rules, standards, or enforcement efforts are needed to protect consumers.
The FTC will be seeking public comment on the following topics with a deadline to submit comments by May 29, 2021.
Defining dark patterns
Prevalence of dark patterns
Factors affecting dark pattern adoption
Dark patterns and machine learning
Effectiveness of dark patterns
Harms of dark patterns
Consumer perception of dark patterns
Market constraints and self-regulation
Solutions
Dark pattern policy discussion has increased over the last few months. If you are a technology stakeholder, it is a discussion to take note of.
Lanton Law is a national boutique law and lobbying firm that focuses on fintech, 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.
U.S. Supreme Court Limits the FTC’s Ability to Obtain Restitution for Deceptive Practices
On April 22, 2021, Justice Breyer wrote the majority opinion for AMG CAPITAL MANAGEMENT, LLC, ET AL. v. FEDERAL TRADE COMMISSION, which was a shock to many consumer advocates where the Court ruled unanimously against the Federal Trade Commission (FTC).
On April 22, 2021, Justice Breyer wrote the majority opinion for AMG CAPITAL MANAGEMENT, LLC, ET AL. v. FEDERAL TRADE COMMISSION, which was a shock to many consumer advocates where the Court ruled unanimously against the Federal Trade Commission (FTC). The ruling could make it less cost effective for the FTC to pursue companies that violate privacy rules.
According to the case, the Federal Trade Commission filed a complaint against Scott Tucker and his companies alleging deceptive payday lending practices in violation of §5(a) of the Federal Trade Commission Act. The District Court granted the Commission’s request pursuant to §13(b) of the Act for a permanent injunction to prevent Tucker from committing future violations of the Act, and relied on the same authority to direct Tucker to pay $1.27 billion in restitution and disgorgement. On appeal, the Ninth Circuit rejected Tucker’s argument that §13(b) does not authorize the award of equitable monetary relief.
The Court held that “Section 13(b) does not authorize the Commission to seek, or a court to award, equitable monetary relief such as restitution or disgorgement.” Congress is set to address this issue soon as it looks to reaffirm the agency’s power to provide consumer relief.
FTC Acting Chairwoman Rebecca Kelly Slaughter released a statement about the case where she stated:
“In AMG Capital, the Supreme Court ruled in favor of scam artists and dishonest corporations, leaving average Americans to pay for illegal behavior,” Acting Chairwoman Rebecca Kelly Slaughter said. “With this ruling, the Court has deprived the FTC of the strongest tool we had to help consumers when they need it most. We urge Congress to act swiftly to restore and strengthen the powers of the agency so we can make wronged consumers whole.”
Over the past four decades, the Commission has relied on Section 13(b) of the Federal Trade Commission Act to secure billions of dollars in relief for consumers in a wide variety of cases, including telemarketing fraud, anticompetitive pharmaceutical practices, data security and privacy, scams that target seniors and veterans, and deceptive business practices, among many others. More recently, in the wake of the pandemic, the FTC has used Section 13(b) to take action against entities operating COVID-related scams. Section 13(b) enforcement cases have resulted in the return of billions of dollars to consumers targeted by a wide variety of illegal scams and anticompetitive practices, including $11.2 billion in refunds to consumers during just the past five years.
Lanton Law is a national boutique law and lobbying firm that focuses on highly regulated industries such as technology, fintech, healthcare and clean energy. 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.
New Congressional Bi-Partisan Privacy Proposal Introduced
A new bi-partisan privacy bill has been introduced by Senators Wyden (D-OR) and Paul (R-KY) titled “The Fourth Amendment is Not For Sale Act.” The bill proposes to close a legal loophole and prevent law enforcement and intelligence agencies from obtaining subscriber or customer records in exchange for anything of value, and to address communications and records in the possession of intermediary internet service providers. Currently, this information can be bought and sold without judicial oversight.
A new bi-partisan privacy bill has been introduced by Senators Wyden (D-OR) and Paul (R-KY) titled “The Fourth Amendment is Not For Sale Act.” The bill proposes to close a legal loophole and prevent law enforcement and intelligence agencies from obtaining subscriber or customer records in exchange for anything of value, and to address communications and records in the possession of intermediary internet service providers. Currently, this information can be exchanged without judicial oversight.
According to the press release, some highlights of the proposal include:
Requires the government to get a court order to compel data brokers to disclose data — the same kind of court order needed to compel data from tech and phone companies.
Stops law enforcement and intelligence agencies buying data on people in the U.S. and about Americans abroad, if the data was obtained from a user’s account or device, or via deception, hacking, violations of a contract, privacy policy, or terms of service. As such, this bill prevents the government buying data from Clearview.AI.
Extends existing privacy laws to infrastructure firms that own data cables & cell towers.
Closes loopholes that would permit the intelligence community to buy or otherwise acquire metadata about Americans’ international calls, texts and emails to family and friends abroad, without any FISA Court review.
Ensures that intelligence agencies acquiring data on Americans do so within the framework of the Foreign Intelligence Surveillance Act and that when acquiring Americans’ location data, web browsing records and search history, intelligence agencies obtain probable cause orders. This language is similar to language that was in the 2020 Wyden-Daines amendment to legislation to reform Section 215.
Takes away the Attorney General’s authority to grant civil immunity to providers and other third parties for assistance with surveillance not required or permitted by statute. Providers retain immunity for surveillance assistance ordered by a court.
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.
House Approves Legislation for Digital Asset Working Group
The Eliminate Barriers to Innovation Act otherwise known as H.R. 1602, sponsored by Rep. McHenry (R-NC) proposes to direct the Commodity Futures Trading Commission and the Securities and Exchange Commission to jointly establish a working group on digital assets.
The Eliminate Barriers to Innovation Act otherwise known as H.R. 1602, sponsored by Rep. McHenry (R-NC) proposes to direct the Commodity Futures Trading Commission and the Securities and Exchange Commission to jointly establish a working group on digital assets. The bill passed the House in a 355-69 vote.
Some of the bill’s highlights include directing the working group to:
Make an analysis of the legal and regulatory framework and related developments in the United States relating to digital assets
Recommend for the creation, maintenance, and improvement of primary and secondary markets in digital assets, including for improving the fairness, orderliness, integrity, efficiency, transparency, availability, and efficacy of such markets;
Make best practice recommendations to reduce fraud and manipulation of digital assets in cash, leveraged, and derivatives markets
If you are a fintech or technology stakeholder who has an interest in digital assets, planning for regulatory oversight should be a part of your business strategy.
Lanton Law is a national boutique law and lobbying firm that focuses on fintech, 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.
Two Biosimilar Bills Head to President Biden for Signature
Two Biosimilar Bills Head to President BIden for Signature
S. 164 titled the “Advancing Education on Biosimilars Act of 2021” sponsored by Senator Hassan (D-NH) has passed both the House and Senate and is on its way to the President. This bill requires the Food and Drug Administration (FDA) to advance education and awareness among health care providers about biological products as appropriate, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars. The FDA may also maintain and operate a website to provide educational materials about biological products.
Additionally, the Ensuring Innovation Act has passed both the House and Senate and is on its way to President for his signature. According to Senator Cassidy’s press release, the bill “would close loopholes to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generics from entering the market.”
Lanton Law is a national boutique 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.
Massachusetts Launches First in the Nation Marijuana Product Catalog For Public Awareness of the Regulated Supply Chain
The Massachusetts Cannabis Control Commission has distributed a press release announcing the first in the nation of a “Product Catalog that will provide the public with a comprehensive database of regulated marijuana products that are sold through the Commonwealth’s licensed Medical Marijuana Treatment Centers (MTCs) and Marijuana Establishments (MEs). The regulatory platform, which is considered the first of its kind in the nation, is hosted through the state’s seed-to-sale system of record, Metrc, and will be embedded on the Commission’s website.”
The Massachusetts Cannabis Control Commission has distributed a press release announcing the first in the nation of a “Product Catalog that will provide the public with a comprehensive database of regulated marijuana products that are sold through the Commonwealth’s licensed Medical Marijuana Treatment Centers (MTCs) and Marijuana Establishments (MEs). The regulatory platform, which is considered the first of its kind in the nation, is hosted through the state’s seed-to-sale system of record, Metrc, and will be embedded on the Commission’s website.”
Furthermore according to the Commission:
“The Commission’s Product Catalog was designed to assist engaged stakeholders, such as school administrators, public safety officials, medical professionals, and parents, with identifying the source of legally produced cannabis merchandise. Under the Commission’s regulations, licensed Marijuana Product Manufacturers must provide information about the marijuana products they will produce and make available at wholesale, after receiving a provisional license and prior to commencing operations in the Commonwealth. Information must include:
The marijuana product type and brand name;
A list of direct and indirect ingredients in the product;
Product serving size, including a description of what constitutes a serving size for a product that is not already a single serving;
Potency;
Photographs of the product both inside its packaging, and outside of and next to its packaging, plus any external or internal packaging; and
A list of marijuana products to be sold based on anticipated or executed agreements between the Marijuana Product Manufacturer and the retail or delivery licensee.
Users will be able to easily look up an item on the Commission’s platform to verify its packaging and labels, ingredients, manufacturing information, which Product Manufacturers produce and wholesale the product in Massachusetts, and more. Marijuana product searches can be completed based on a product name, category, keywords, or other unique identifiers.”
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically our cannabis practice helps all supply chain entities from growers, financiers, suppliers, dispensers to ancillary services.
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.
Congressional Legislation on Big Tech is Forthcoming
The U.S. House Antitrust Subcommittee Chairman Cicilline (D-RI) issued a statement shortly after the Committee marked up and approved the Committee’s report which after a 16 month investigation examined the state of competition within the digital economy.
The U.S. House Antitrust Subcommittee Chairman Cicilline (D-RI) issued a statement shortly after the Committee marked up and approved the Committee’s report which after a 16 month investigation examined the state of competition within the digital economy.
The Congressman’s statement stated:
“Amazon, Apple, Google, and Facebook each hold monopoly power over significant sectors of our economy. This monopoly moment must end. I’m grateful to my colleagues on both sides of the aisle who worked with me over the past two years to compile this Report, which makes clear that Congress and the antitrust enforcement agencies must step up to restore a competitive marketplace, enhance innovation, and protect our democracy. Now that the Judiciary Committee has formally adopted our findings, I look forward to crafting legislation that addresses the significant concerns we have raised.”
The report is expected to become an official committee report shortly. Lanton Law has been closely monitoring legislation from Senator Klobuchar (D-MN) and Congressman Cicilline (D-RI) and we strongly believe that this year we will see legislation based off of this Committee report to strengthen antitrust laws aimed at tech companies.
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.