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This digest covers key virtual and digital health regulatory and public policy developments during June 2023 from the United States, United Kingdom, and European Union.

In this issue, you will find the following:

U.S. News

EU and UK News

U.S. News

FDA Regulatory Updates

FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions. On June 14, 2023, FDA issued a final guidance titled “Content of Premarket Submissions for Device Software Functions” (the Final Guidance or the Guidance). This Guidance finalizes a draft guidance issued in November 2021 and supersedes a May 2005 guidance on premarket submissions for software contained in devices. The Final Guidance applies to devices that contain one or more software components, parts, or accessories, or are composed solely of software, and applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.

As further detailed in the Final Guidance, the extent of documentation that FDA recommends including in submissions for software devices is proportional to the “level of concern” associated with the device. The “level of concern” (Level of Concern) refers to an estimate of the severity of injury that a device could permit or inflict as a result of design failure, design flaws, or simply by virtue of employing the device for its intended use. The Guidance explains that the Level of Concern (major, moderate, or minor) is not related to a device’s classification (Class I, II, or III) or to its hazard or risk analysis per se. The Guidance outlines questions to consider in determining the Level of Concern for a software device. Notably, under the Guidance framework, if a software device is intended to be used in combination with a drug or biologic, the level of concern is likely to be “major.”

The Guidance also provides recommendations on the documentation to include in a premarket submission, consistent with the device’s Level of Concern and the type of submission (e.g., documentation relating to device hazard analysis, design specifications, traceability analysis, verification and validation, or unresolved anomalies).

Owlet Receives FDA Clearance for Pulse Oximetry Sock Following FDA Warning Letter. In a press release issued June 20, 2023, Owlet announced that it had received FDA-clearance for BabySat™, the first medical pulse-oximetry device featuring Owlet’s wire-free sock design. This announcement follows a Warning Letter FDA issued to Owlet in October 2021 alleging the company’s smart sock products were devices. As further detailed in the January 2023 issue of our digest, following receipt of the Warning Letter, Owlet’s website indicated that Owlet was “no longer selling the Smart Sock in the US,” and Owlet later announced it had both a de novo submission and 510(k) submission pending with FDA. As described in the 510(k) clearance, Owlet’s newly cleared BabySat™ device is a pulse oximeter indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between six and 30 pounds in the home environment. BabySat™ is cleared only for prescription use.

FDA Issues Warning Letter to Vitang Technology LLC for Implementing Device Software Changes Without Clearance. In last month’s digest, we reported on a recent FDA Warning Letter issued to iRhythm Technologies Inc. (iRhythm) where FDA alleged iRhythm was marketing its software-based cardiac-monitoring device outside the scope of its 510(k) clearance. A few short weeks later, FDA issued yet another Warning Letter to the sponsor of a digital health device, this time focusing on the sponsor’s failure to obtain marketing clearance for software changes. The Warning Letter was issued to Vitang Technology LLC (Vitang) in relation to its UniSmile Clear Aligner System, a 510(k)-cleared dental aligner system. In addition to various quality system violations, FDA asserts that, as a result of changes in the software used for the development of treatment plans for the UniSmile Clear Aligner System, Vitang was required to file a new 510(k). Notably, FDA also took issue with Vitang describing the device as “FDA-approved” on the device’s website and incorporating the FDA logo in marketing materials, which the agency states misbrands the device.

CDRH Director Weighs in on CDS Guidance Enforcement Discretion Policy Change. Regular readers of our digest may recall that FDA’s finalization of the clinical decision support (CDS) software guidance in September 2022 was met with much controversy, as the final guidance described narrower enforcement discretion categories for CDS tools than articulated in a 2019 draft guidance (which itself had replaced a 2017 draft guidance). In what may come as a surprise to some in the industry, at a recent conference, Director Jeffrey Shuren of the Center for Devices and Radiological Health (CDRH) suggested the enforcement discretion policy described in the 2019 draft guidance was the problem, not the final guidance policy. As reported by AgencyIQ, at the FDLI Annual Conference, Director Shuren stated: “Here’s the bottom line — we issued two drafts, [and] the second draft was the overreach.” Director Shuren also opined that the enforcement discretion categories included in the 2019 draft guidance “went well beyond what Congress ever put into the statute.”

For more information about the CDS Guidance, see the November 2022 issue of Arnold & Porter’s Virtual and Digital Health Digest.

Healthcare Fraud and Abuse Updates

DOJ’s Continued Focus on Telehealth and Medically Unnecessary Services. On June 28, 2023, the DOJ, along with state and federal law enforcement partners, announced a two-week nationwide law enforcement action. In relevant part, DOJ filed charges against 11 defendants in connection with the submission of over US$2 billion in fraudulent claims resulting from telemedicine schemes. Specifically targeting elderly and disabled patients, the defendants allegedly operated a software platform that was a conduit for telemarketers to coordinate payment of illegal kickbacks and bribes to telemedicine companies in order to acquire doctors’ orders for Medicare beneficiaries. The defendants programmed the software to generate false and fraudulent orders stating that telemedicine doctors had examined beneficiaries in person when these interactions had occurred remotely using telemedicine. The software was also programmed to falsify orders on diagnostic testing that Medicare required for brace orders. This alleged conspiracy resulted in the submission of US$1.9 billion in false and fraudulent claims to Medicare and other government insurers for orthotic braces, prescription skin creams, and other medically unnecessary items.

Genetic testing telehealth schemes also continue to be an enforcement focus. On June 13, 2023, a physician assistant, Colby Edward Joyner, was found guilty for his role in a genetic testing scheme for signing fraudulent prescriptions for medically unnecessary genetic testing. Joyner submitted medically unnecessary claims for cancer genomic and pharmacogenetic testing for hundreds of Medicare beneficiaries residing in North Carolina with whom Joyner either only had brief telephone conversations or no interactions at all. This scheme resulted in the submission of over US$10 million in fraudulent claims to the Medicare program. Also, on June 26, 2023, Michael Stein pleaded guilty to his role in a US$73 million Medicare telehealth fraud scheme where he recruited telemedicine providers to authorize genetic testing and referred orders to laboratories in exchange for kickbacks. Telehealth genetic testing schemes continue to be a priority enforcement area for law enforcement.

Provider Reimbursement Updates

UnitedHealthcare Expands Telehealth Benefit. UnitedHealthcare announced its plan to eliminate enrollee cost sharing (co-pay, deductible, and coinsurance) for “24/7 Virtual Visits.” Beginning July 1, 2023, and through at least the end of plan year 2024, enrollees in eligible fully insured employer-sponsored plans will be eligible for this benefit upon renewal and new enrollees will have access to this benefit right away. UnitedHealthcare estimates 25% of emergency room visits could be treated with a virtual visit. Depending on the specific plan, patients can also use virtual visits for primary care visits, behavioral health visits, and specialty care visits.

Medicare Telehealth Proposals. On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2024 Medicare Physician Fee Schedule (PFS) proposed rule. The rule proposes several changes related to telehealth reimbursement. In particular, CMS proposes to:

  • Simplify its process for submitting requests to the Medicare Telehealth Services List beginning in CY 2025, by replacing the Category 1-3 designations that CMS used during the Public Health Emergency (PHE) with two designations – permanent or provisional. 
  • Move any services currently on the Medicare Telehealth Services List on a Category 1 or 2 basis to the proposed “permanent” category and to move services that are currently on the “temporary Category 2” or Category 3 basis to the “provisional” status.
  • Use a 5-step process to determine whether a submission to the Medicare Telehealth Services List should be granted and seeks comments on the proposed analysis procedures for additions to, removals from, or changes in status for services on the Medicare Telehealth Services List.
  • Allow teaching physicians to have a virtual presence (excluding audio-only) in “all teaching settings, only in clinical instances when the service is furnished virtually (for example, a 3-way telehealth visit, with all parties in separate locations)” through December 31, 2024. According to CMS, this will allow “teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment is sought.”
  • Recognize as telehealth practitioners mental health counselors and marriage and family therapist, who are new practitioners recognized under Medicare, effective January 1, 2024, as a result of the Consolidated Appropriations Act, 2023.

CMS also clarifies that qualified physical therapists, occupational therapists, speech language pathologists, and audiologists can continue to bill under the Medicare Telehealth Services list until the end of CY 2024, consistent with provisions of the Consolidated Appropriations Act of 2023. CMS seeks to “retain payment stability, reduce confusion and burden, and conform to all statutory requirements without unnecessary restrictions on beneficiaries’ access to care.” Finally, to gather more information on how remote patient monitoring is used in clinical practices, CMS also seeks comment on the effectiveness and information related to digital therapeutics.

Privacy Updates

FTC Charges Genetic Testing Company With Data Privacy and Security Violations. In what the agency says is its first case focused on both the privacy and security of genetic information, the Federal Trade Commission (FTC) recently commenced an action against 1Health.io Inc., operating as Vitagene, for allegedly failing to protect sensitive genetic and other personal health information and misleading consumers about its privacy and security practices. Vitagene, which offers consumers digital analyses of their genetics and health, states on its website that “Protecting your privacy is of utmost importance to us. We deploy industry’s best practices to protect your data…. Vitagene is compliant with HIPAA, GDPR and all related health information regulations.” According to the FTC, however, Vitagene’s assertions as to data protection are inconsistent with the company’s practices, and therefore the company violated the prohibition on unfair and deceptive practices in Section 5 of the FTC Act.

Vitagene uses saliva-based DNA health test kits, online questionnaires, and raw DNA material to generate personalized health, wellness, and ancestry reports. According to the FTC’s complaint, Vitagene stores the full names of its customers along with numerous facts about their genetics and health, and while professing to maintain “[r]rock-solid [s]ecurity,” the company “publicly exposed online the health and genetic information of more than 2,600 consumers” through its cloud service provider. The cloud service provider reportedly warned Vitagene about the exposure, but, the FTC alleges, Vitagene failed to respond promptly to those warnings. The complaint also alleges that Vitagene deceived consumers by changing its privacy practices without proper notice.

Under a proposed FTC settlement, Vitagene will pay $75,000 in monetary relief, intended to be distributed to affected consumers. The company also will be prohibited from disclosing any individual’s identifiable health information to third parties without the affirmative express consent of the individual. And, as is typical of FTC settlement orders in data privacy and security cases, Vitagene will be required to establish, implement, and maintain a comprehensive information security program and to notify the FTC about any future unauthorized disclosures of consumers’ personal health data.

This action follows the FTC’s recent actions against GoodRx, BetterHelp, and Premom. In these actions, FTC similarly claimed that the respondents misled consumers by promising privacy protections for personal health information that allegedly were inconsistent with actual practice.

New Data Privacy Framework May Facilitate Personal Data Flows From the EU to the U.S. After years of negotiation, the European Commission (Commission) has formally adopted a new adequacy decision providing a data protection framework (Framework) to facilitate transfers of personal data from the European Union (EU) to the United States in compliance with the General Data Protection Regulation (GDPR). Under the GDPR, entities within the EU may transfer personal data to a non-EU jurisdiction only if the Commission has determined that such jurisdiction has “adequate” privacy laws to protect the data or if another Commission-approved mechanism is in place to protect the privacy and security of the data post-transfer.

To date, the Commission has not found U.S. privacy laws to be “adequate” for purposes of the GDPR’s data transfer restrictions. Therefore, other Commission-approved mechanisms have been required. Following negotiations with the U.S. Department of Commerce, the Commission previously approved two frameworks that gave U.S. companies the option to certify to protect personal data under GDPR-like standards and made personal data transfers to those companies permissible for EU-based entities. Both of those prior frameworks (the Safe Harbor and Privacy Shield frameworks), however, were challenged as insufficiently protective of personal information and invalidated by the European Court of Justice. As a result, since 2022, transfers of personal data from the EU to the United States have been permissible only pursuant to Standard Contractual Clauses (SCCs) binding U.S. recipients of personal data to stringent data protection commitments made to the EU-located exporters of such data.

Adopting the SCCs on a case-by-case basis is generally very cumbersome for companies that engage in frequent EU-U.S. personal data transfers. The decision is therefore welcomed by many, albeit with trepidation, given the high likelihood that it will face a challenge similar to those that led to the demise of the Safe Harbor and Privacy Shield in the European Court of Justice.

For now, U.S. companies may want to consider the advantages of the Framework for the next several years. To benefit from the Framework, a U.S. company must submit an application to the Commerce Department that includes a certification of compliance with the data protection principles adopted in the decision. Although failure to comply with these principles would subject a certified company to potential investigation and enforcement by the Federal Trade Commission (or in some cases, the Department of Transportation), by relieving the company of the burden of executing SCCs, the certification’s benefits may outweigh its risks for many companies.

Corporate Transactions Updates

Digital Health Companies Fight for Spot in Booming US$13 Billion Weight Loss-Care Market. Telehealth and digital health companies are competing for a spot in the US$13 billion global obesity therapeutic market, which is expected to grow to US$50 billion in sales with a market value of US$100 billion by 2030. In 2022 alone, over five million prescriptions were written for Ozempic, Mounjaro, and Rybelsus (GLP-1 drugs) to treat weight management, a 2,082% increase from the previous year. Over the past few months, numerous health companies have attempted to capitalize on these new therapeutic regimens by entering the telehealth weight-loss market, including Noom, Teladoc, and WeightWatchers.

In May 2023, digital health company Noom announced it was launching a new dedicated service-line called Noom Med providing individualized telemedicine based obesity treatment for approximately $120 a month. Noom Med now integrates Noom’s psychology-based behavior modification programs with clinical specialists and therapeutics to provide a pathway for long-term maintenance of a healthy weight and avoidance of chronic illness associated with obesity. During the same period, telehealth giant Teladoc announced the expansion of its provider-based care services to include weight management and prediabetes programs including optimizing the use of various obesity drugs such as Wegovy. This expansion coincided with the share price of Teladoc jumping 11%. In March 2023, WeightWatchers acquired telehealth company Sequence for US$132 million, allowing WeightWatchers to integrate telehealth care for weight loss into its model, including access to various prescription weight-loss drugs.

During the same period, telehealth giant Teladoc announced the expansion of its provider-based care services to include weight management and prediabetes programs including optimizing the use of various obesity drugs such as Wegovy. This expansion coincided with the share price of Teladoc jumping 11%. In March 2023, WeightWatchers acquired telehealth company Sequence for US$132 million, allowing WeightWatchers to integrate telehealth care for weight loss into its model, including access to various prescription weight-loss drugs.

While companies such as Noom, Teladoc, and WeightWatchers have attempted to secure their spot in the competitive weight-loss market by making access to weight-loss medications easier for patients, other digital health companies, such as Prism Labs, which provides 3D body compositions, are seeking to use their already developed technology in tandem with weight-loss drugs. Other digital health companies not traditionally associated with weight loss, such as Hims & Hers, have signaled they are exploring options to find a spot in the booming weight-loss market.

Policy Updates

White House Opposes House-Passed Telehealth Extension Legislation. In June 2023, the House Ways and Means and Education and Workforce Committees passed legislation to (1) permanently exempt high-deductible health plans (HDHPs) from the requirement of a deductible for telehealth and other remote care services and (2) extend flexibilities established during the COVID-19 pandemic to allow for expanded coverage of telehealth services offered under a group health plan or group health insurance coverage. The safe harbor for telehealth services from the deductible in HDHPs was established originally under the Coronavirus Aid, Relief, and Economic Security Act (CARES) Act (H.R. 748, 116th Congress) as a response to the COVID-19 pandemic and has been extended to the start of 2025. While House Republicans argued these bills would improve rural access to healthcare, the White House published a Statement of Administration Policy (SAP) in opposition to the CHOICE Arrangement Act (H.R. 3799), which likely means the Democratically controlled Senate will not consider the legislation in this congressional term.

Recent Legislative Efforts to Regulate AI:

  • Schumer Moves Forward With Senator-Level AI Briefings. On July 9, 2023, Senate Majority Leader Chuck Schumer (D-NY) published a Dear Colleague letter in which he laid out many legislative priorities the Senate will be focused on during the remainder of 2023. Specifically, Leader Schumer prioritized the development of the SAFE Innovation Framework for Artificial Intelligence (AI) and announced the “first-ever” classified Senator-level briefing with the Department of Defense and Intelligence Community to discuss the role of AI in U.S. national security. Among many other issues, Leader Schumer discussed his plan to consider legislation to fund the government in fiscal year (FY) 2024, pass the National Defense Authorization Act (NDAA), and consider bipartisan legislation to lower the cost of insulin and prescription drugs. 
  • Bipartisan House Bill to Create AI Commission. On June 20, 2023, Reps. Ted Lieu (D-CA), Ken Buck (R-CO), Anna Eshoo (D-CA), and Sen. Brian Schatz (D-HI) announced the introduction of the National AI Commission Act (H.R. 4223), which would create a “bipartisan, blue ribbon commission” to review Congress’ approach to regulating AI and weigh the social costs and benefits associated with legislative decisions. The same day, President Joe Biden met with AI policy experts from a variety of organizations to discuss a path forward for AI regulation. Following the meeting, President Biden delivered remarks underscoring his administration’s commitment to addressing AI risks while fostering innovation.
  • FDA Eyes New Regulation on Generative AI. Last month, during a Biotechnology Innovation Organization (BIO) convention, FDA Commissioner Robert Califf said certain language models used in generative AI, including ChatGPT, are transforming the development of new drugs and therapies which necessitates FDA to promulgate future regulations. Commissioner Califf claimed industry leaders “want to be regulated” in this space, yet there are few “good suggestions” on how best to regulate this emerging technology. 

EU and UK News

Regulatory Updates

Launch of New Digital Health Partnership Between the European Commission and WHO. On June 5, 2023, the World Health Organization (WHO) and European Commission (EC) announced the launch of a digital health initiative to strengthen global health security. The partnership aims to foster the development and implementation of digital tools and technologies that can support timely and effective response measures during health crises. The first step is for the WHO to build upon the EU’s Digital COVID-19 Certification (EU DCC) system and create a global system, which will form part of the WHO Global Digital Health Certification Network (GDHCN). In doing so, the EC will share its technical expertise in developing the EU DCC, for example in standard-setting and validation of digital signatures to prevent fraud. Subsequently, the EC and WHO will work on additional digital solutions, such as the digitization of the International Certificate of Vaccination.

Launch of the UK AI and Digital Regulations Service. On June 12, 2023, NHS launched the Artificial Intelligence and Digital Regulations Service. The new online advisory service is designed to aid the NHS and wider care system in fully leveraging the latest digital and AI technologies. The service is a joint collaborative effort between the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare Products Regulatory Agency (MHRA), the Health Research Authority (HRA), and the Care Quality Commission (CQC). It provides centralized and up-to-date guidance for developers and adopters of digital innovations and provides specialist support to developers and innovators in response to individual queries.

European Parliament Ready to Start Negotiating the EU AI Act. On June 14, 2023, the European Parliament (EP) adopted the text for its negotiation mandate for the EC’s proposals on the EU AI Act that were published in April 2021. As described in our June digest, the EP has expanded the list of AI systems, which are deemed to pose an unacceptable level of risk to people’s safety, to include intrusive and discriminatory uses of AI. Other proposed amendments are the inclusion of transparency obligations on developers of generative AI systems and the addition of exemptions for research activities to encourage innovation and testing in regulatory sandboxes prior to deployment. The next step is negotiations between the European Council and the Commission with the aim for agreement on the final text by the end of 2023. Please read our Advisory here.

Comments on the EU AI Act From Healthcare Industry Stakeholders. On June 14, 2023, MedTech Europe, together with 10 other healthcare stakeholders, published a joint statement on how the proposed EU AI Act could be improved and clarified during the upcoming negotiations, in light of the potential benefits AI could have on health systems. The stakeholders outlined four key considerations:

  • The AI Act must be consistent with existing and forthcoming horizontal and sectoral European laws, e.g., device legislation, the General Data Protection Regulation (GDPR), the new AI Liability Directive, the revised Product Liability Directive, and the European Health Data Space Regulation. The stakeholders support the EP’s position that obligations relating to high-risk AI systems would be deemed fulfilled if already addressed by sectoral legislation. 
  • The definitions of “user,” “risk,” and “AI systems” need to be clarified, with the stakeholders welcoming the EP’s suggestions in this regard.
  • A clear data and data governance framework should be established under the AI Act, removing the unrealistic condition that “error-free and complete” data should be used for training, validation, and testing of AI systems. The stakeholders argue that such a condition would prevent the use of real-world data. The EP’s proposed obligation on member states to promote AI literacy among providers, deployers, and users is also welcomed.
  • The AI Act must ensure uniform implementation and enforcement across the EU, e.g., through the establishment of an AI Board and the AI Office.

UK CDEI Guidance on Developing Trustworthy AI. On June 7, 2023, the UK’s Centre for Data Ethics and Innovation (CDEI) released a portfolio of AI assurance techniques to support stakeholders involved in AI development, deployment, and procurement in developing trustworthy practices. Such techniques include impact assessment, impact evaluation, bias audit, compliance audit, certification, conformity assessment, performance testing, and formal verification. These techniques can be employed across the AI lifecycle and are exemplified across 14 real-world case studies. They are also mapped onto the five principles for AI regulation outlined in the UK government’s AI White Paper (discussed in our April digest). The CDEI states that the portfolio will be regularly updated to incorporate emerging best practices.

In accordance with the principle of fairness, on June 14, 2023, the CDEI also published a report on approaches for organizations building or deploying AI systems to access data on the demographics of their users to assess potential bias. The CDEI has also launched a “Fairness Innovation Challenge” to help generate new approaches to address bias in AI systems.

Privacy and Cybersecurity Updates

Industry stakeholders’ position on the opt-out mechanism in the EHDS. On June 6, 2023, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and MedTech Europe, alongside 30 other health stakeholders, issued a joint statement addressing the potential implementation of an opt-out mechanism within the European Health Data Space (EHDS). This statement coincides with ongoing discussion in the EU policy-making process to include an opt-out mechanism, allowing citizens or countries to withdraw their data from secondary use purposes such as research and regulatory activities. The stakeholders endorse the approach taken in the Commission’s legislative proposal from May 2022, which aimed to strike a balance between privacy protection and leveraging health data for research advancements and societal benefits — and which did not include an opt-out mechanism. The group expressed concerns about the risk of data bias if the mechanism is approved, and put forth six recommendations for co-legislators to consider in ensuring the effective secondary use of health data. Such recommendations include that the mechanism should be applicable in all EU member states, be transparent in scope, and be clear to EU citizens.

Reimbursement Updates

EFPIA Report on Improving Access to Digital Therapeutics. On June 2, 2023, EFPIA issued a report and policy recommendations regarding ways to improve access to digital therapeutics (DTx) in the EU. The report describes the limited availability of DTx in the majority of European countries due to four key barriers:

  • The lack of harmonization in regulatory requirements for certification of DTx as a medical device
  • Challenges in evidence requirements for DTx value assessment
  • The lack of a specific reimbursement pathway for DTx in most of EU countries
  • Inadequate funding for DTx

Germany and Belgium are identified as the EU countries most advanced in these respects, with both having a national value assessment framework, a national reimbursement pathway, and available funding mechanisms for DTx, as discussed in previous digests. It is also noted that the UK’s National Institute for Health and Care Excellence (NICE) has developed an evidence standards framework for digital health technologies for value assessment, but that a specific reimbursement pathway is still lacking.

EFPIA proposes nine policy recommendations to improve access to DTx, including, for example, the development of innovative reimbursement models (e.g., outcome-based agreements using patient-reported outcome measures) and payers permitting flexible approaches to access while additional data is collected.

Product Liability Updates

European Council Position on New Product Liability Directive. On June 9, 2023, the European Council published its position on the proposal for a directive on liability for defective products, discussed in our November digest. The Council’s proposed text is broadly aligned with the Commission’s proposal. However, of note, the Council has proposed a 20-year-long stop date for latent injury (rather than 15 years) and has reintroduced the position whereby member states can choose to derogate from the development risks defense, which is the position under the current directive. In addition, there is a new article whereby “any failure of the product to fulfil its purpose of preventing damage” is a relevant circumstance for assessing whether a product is defective and may be particularly relevant for products marketed as having a protective effect; this could include, for example, medical devices. Negotiations will recommence soon, with institutions seeking to agree an compromise text before voting. Policymakers have stated that they intend to finalize the revisions before the European Parliament elections next year.

* Mickayla Stogsdill contributed to this Newsletter. Mickayla is employed as a Senior Policy Specialist at Arnold & Porter’s Washington, D.C. office. Mickayla is not admitted to the practice of law.

* Katie Brown contributed to this Newsletter. Katie is employed as a Policy Advisor at Arnold & Porter’s Washington, D.C. office. Katie is not admitted to the practice of law.

* Tia Archer contributed to this Newsletter. Tia was employed as a Legal Intern at Arnold & Porter’s London office as part of the #10000 Black Interns program. Tia is not admitted to the practice of law.

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© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.