This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024 from the United States, United Kingdom, and European Union.
In this issue, you will find the following:
U.S. News
- FDA Regulatory Updates
- Health Care Fraud and Abuse Updates
- Corporate Transactions Updates
- Provider Reimbursement Updates
- Policy Updates
- Privacy and AI Updates
U.S. Featured Content
The Federal Trade Commission (FTC) released final amendments to its Health Breach Notification Rule (the HBNR) broadening the inclusion of health apps and other digital health tools that collect personal health information, primarily from consumers, as vendors of personal health records (PHRs). Moreover, these amendments codify the FTC's position that a "breach of security" under the HBNR means an unauthorized disclosure of identifiable health information regardless of whether the disclosure occurred as a result of a technological flaw, third-party intrusion, hacking, or other occurrence commonly understood as a "security breach."
EU and UK News
EU/UK Featured Content
France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.
U.S. News
FDA Regulatory Updates
FDA Exploring Potential Use of Algorithms To Predict Drug
Shortages. On April 11, 2024, Food and Drug
Administration (FDA) Commissioner Robert Califf testified before
the House Oversight & Accountability Committee. As reported by
InsideHealthPolicy, during his testimony Califf stated
that enhanced manufacturer reporting requirements, which FDA has
requested Congress establish as part of its fiscal year 2025
budget, could be used to create predictive algorithms that would
increase FDA's knowledge of the drug supply chain and help FDA
anticipate shortages. Califf explained that manufacturers are
required to report certain information to FDA but "they
resist[] giving [FDA] some of the crucial information that [FDA]
really need[s] ... it'd be better if [FDA] had all the data
[the agency] needed to put together predictive algorithms that
would allow [FDA] to intervene preemptively much, much earlier and
prevent the shortage."
FDA Qualifies Apple AFib App for Data Collection in
Certain Clinical Trials. On May 1, 2024, FDA qualified
the Apple Atrial Fibrillation (AFib) History Feature, the first
digital health technology qualified under the MDDT program. Apple's AFib History Feature
is a medical device that previously received 510(k) clearance as an
over-the-counter software-only mobile medical application intended
for users 22 years of age and over who have a diagnosis of AFib.
The feature works by analyzing Apple Watch pulse rate data to
identify episodes of irregular heart rhythms suggestive of AFib and
provides the user with a retrospective estimate of AFib burden (a
measure of the amount of time spent in AFib during past Apple Watch
wear).
As qualified by FDA under the MDDT program, the AFib History Feature is intended to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices. Specifically, it may be used to compare weekly estimates of AFib burden before and after cardiac ablation treatment. However, data obtained from the device is not intended to replace the findings of any primary endpoints (i.e., it cannot alone be used to determine the safety and efficacy of cardiac ablation devices). The performance testing that FDA used to support qualification of the AFib History Feature as a biomarker test for the qualified context of use was derived from the evidence Apple submitted in support of the product's 510(k) device clearance.
Health Care Fraud and Abuse Updates
DOJ Continues To Pursue Durable Medical Equipment
Cases. The U.S. Department of Justice's (DOJ) focus on
durable medical equipment (DME) schemes continued to persist in the
month of April. On April 26, 2024, Manishkumar Patel pleaded guilty for his role in a
US$50 million health care fraud and kickback scheme. This
scheme concerned the sale of fraudulent prescriptions and
doctors' orders for DME, laboratory tests, and pharmaceuticals
(scripts) between 2019 and 2022. DME and supplies were allegedly
furnished to suppliers, laboratories, and pharmacies that obtained
payment for the fraudulent prescriptions from Medicare. Patel
allegedly acquired the scripts from call centers that contacted
Medicare beneficiaries to ask them questions designed to justify a
script reimbursable by Medicare. Patel turned the information from
these calls into scripts, arranging cursory telemedicine
appointments with Medicare beneficiaries. Patel engaged in
"doctor chasing," where information was sent to doctors
to sign scripts despite the doctors often being unaware of what
they were signing, and signing the scripts without actually seeing
the patient. Patel would then sell the forged scripts to Medicare
providers that filled the orders and billed Medicare.
Further, on April 4, 2024, Steven Richardson, the owner of
Expansion Media and Hybrid Management Group, pleaded guilty in connection with a
telemedicine fraud scheme involving medically unnecessary durable
medical equipment, including orthotics such as back and knee
braces, resulting in the billing of US$110 million in fraudulent
Medicare claims. See the
March 2024 digest for an overview of the charges in this
case.
Corporate Transactions Updates
A Snapshot of Digital Health During Q1 2024.
U.S. Digital health funding had a 48% quarter-over-quarter jump in Q1 2024, with
a total of US$2.7 billion invested across 133 deals,
averaging a deal size of US$20.6 million. This growth in funding is
tempered by the fact that Q4 2023 was the lowest funding quarter in
over three years, and the significant deployment of funds can be
largely attributed to a handful of mega-funding-rounds.
Digital health "winners'' in Q1 2024 include Abridge,
an AI-enabled clinician scribe software company that raised US$150 million in Series C funding on February
23, 2024, and DecisionRx, a medication management digital health
company that secured US$100 million in funding in the form of a debt
facility from investment firm Carlyle on January 11, 2024.
However, not all fared as well, with UnitedHealth Group announcing
it was ending its telehealth offerings, and
telehealth company Amwell facing a
potential boot from the New York Stock Exchange for its stock
price trading below the minimum standard for listing.
Notable transactions in the beginning of Q2 include Nuvo Group Ltd,
a remote pregnancy monitoring company that combined its business
assets through a special purpose acquisition company with LAMF Global Ventures Corp. on May 1, 2024, and
Transcarent, an AI-focused digital health
startup that received a US$126 million series D round on May 2,
2024.
Provider Reimbursement Updates
CMS Releases Fiscal Year 2025 IPPS Proposed Rule. On May 2, 2024, Centers for Medicare & Medicaid Services (CMS) published its proposed rule on the Medicare Inpatient Prospective Payment System (IPPS) for fiscal year 2025.
Among other updates, CMS proposed a new mandatory episode-based alternative payment model for selected acute care hospitals that would coordinate care for beneficiaries that undergo certain surgical procedures, including coronary artery bypass, lower extremity joint replacement, and spinal fusion. Under the proposed model, hospitals would assume responsibility for the cost and quality of care from surgery through the first 30 days after discharge.
CMS anticipates the episode-based payment model, titled the Transforming Episode Accountability Model (TEAM), would lead to greater interest among hospitals in using telehealth for post-discharge care.
Accordingly, CMS has proposed to waive certain statutory telehealth restrictions for services provided to TEAM beneficiaries. Specifically, CMS would waive the geographic restriction that limits telehealth services to rural, underserved areas and originating site restriction to allow TEAM beneficiaries to receive telehealth services in their homes or places of residence. CMS stated such waivers would be "essential to maximize the opportunity to improve the quality of care and efficiency for episodes of care in TEAM."
CMS proposes that all other Medicare coverage and payment criteria would apply and no additional payment would be made to cover set-up costs, technology purchases, training, or other associated costs. Additionally, the facility fee ordinarily paid by Medicare to an originating site for telehealth services would be waived if the service originates from the beneficiary's home.
CMS also proposes to create a set of codes to describe evaluation and management services furnished to TEAM beneficiaries in their homes via telehealth and develop associated payment rates.
As we covered in the
November 2023 digest, CMS waived the above and other
restrictions on telehealth services during the COVID-19 Public
Health Emergency. Those flexibilities are set to expire at the end
of the year, absent action by Congress.
Policy Updates
Congressman Buchanan Leads Letter on Artificial Intelligence Issues in U.S. Health Care Systems. On April 18, 2024, House Ways & Means Health Subcommittee Chairman Vern Buchanan (R-FL) led a letter to the Medicare Payment Advisory Commission (MedPAC) criticizing the commission's latest recommendations related to coverage and reimbursement of digital health tools and prescription digital therapeutics. Congressman Buchanan thinks MedPAC has limited itself too much in scope as it relates to the utilization of artificial intelligence and urges MedPAC to "explore digital health's role in improving outcomes and lowering costs in the face of an overwhelming evidence base demonstrating these tools' ability to deliver value to Medicare beneficiaries and providers." Congressman David Schweikert (R-AZ) and Congresswoman Michelle Steel (R-CA) also signed the letter.
Privacy and AI Updates
Federal Trade Commission Adopts Final Modifications to
Health Breach Notification Rule. On April 26, 2024, the
FTC released final amendments to its Health Breach Notification
Rule, which were the subject of a notice of proposed rulemaking
issued in June 2023 and reflect comments from numerous interested
parties. The HBNR, which largely parallels the Health Insurance
Portability and Accounting Act (HIPAA) breach notification
regulations applicable to HIPAA "covered entities" and
their "business associates," requires "vendors"
of "personal health records" that are not regulated by
HIPAA to notify the FTC and affected individuals (and in some
cases, the media) of a breach in the security of unsecured
individually identifiable health information. For a decade after
the HBNR was initially adopted in 2009, the rule got little
attention, in part because there was a general understanding that
the rule's definition of "PHR vendor" was quite
limited in scope. However, in 2020, the FTC revisited that
definition in light of the proliferation of mobile apps and other
direct-to-consumer health technologies, such as fitness trackers
and wearable blood-pressure monitors. After requesting comments on
whether such technologies were properly understood to be PHR
vendors within the meaning of the HBNR, the FTC issued a policy statement in September 2021, in which
it declared that health apps and other digital health tools that
collect personal health information, primarily from consumers, are
vendors of PHRs. The new amendments codify this interpretation,
making a wide variety of digital health technologies clearly
subject to the HBNR.
In addition to effecting this "clarification," the new
amendments codify the FTC's position that a "breach of
security" under the HBNR means an unauthorized disclosure of
identifiable health information regardless of whether
the disclosure occurred as a result of a technological flaw,
third-party intrusion, hacking, or other occurrence commonly
understood as a "security breach." That is,
under the new amendments, a "breach of security"
includes, for example, a disclosure of individually identifiable
health information by a PHR vendor in a manner inconsistent with
representations made by the vendor about how it handles such
information (which the FTC would also consider a deceptive practice
actionable under Section 5 of the FTC Act). A "breach of
security" also might include a disclosure of a consumer's
individually identifiable health information for purposes of
targeted advertising if the consumer had not consented to such
disclosure.
The impact of the new amendments for digital health technologies is
significant, in part because the FTC's enforcement tools under
the HBNR are more extensive than the remedies the agency may seek
under the FTC Act itself.
Colorado Legislature Adopts Bill To Regulate AI.
On May 8, 2024, the Colorado legislature passed the Colorado Artificial Intelligence Act (SB 205),
designed to protect consumers from the risks associated with the
use of AI in making certain impactful decisions. If the bill is
signed into law by Governor Jared Polis, it will be the first U.S.
state law broadly regulating developers and deployers of AI
systems.
SB 205 specifically targets developers and deployers of any
"high-risk AI system," which it defines as an
"artificial intelligence system that, when deployed, makes, or
is a substantial factor in making, a consequential decision."
A "consequential decision" in
this context is "a decision that has a material legal or
similarly significant effect on the provision or denial to any
consumer of, or the cost or terms of, e.g., education and
employment opportunities and financial services." A
"substantial factor"
contributing to such a decision would include any "use of an
AI system to generate any content, decision, prediction, or
recommendation concerning a consumer that is used as a basis to
make a consequential decision concerning the consumer." To
protect against misuse of high-risk AI systems in making
"consequential decisions" about consumers, developers and
deployers of such systems would be liable if they failed to use
"reasonable care" to avoid algorithmic discrimination in
such systems.
Like many state privacy laws, SB 205 requires that regulated
entities provide certain notices to consumers. Among other things,
the bill requires deployers to notify consumers of, among other
things, the purpose of the AI system and the nature of the
consequential decision and, if applicable, the consumers' right
to opt out of the processing of personal data for profiling
purposes under the Colorado Privacy Act. And, in addition to
establishing specific standards for the use of "high-risk AI
systems," the bill requires deployers of such systems to
complete impact assessments annually and within 90 days of any
intentional or substantial modification to their high-risk AI
systems.
If enacted, SB 205 will take effect on February 1, 2026. It will be
enforceable by the Colorado attorney general only; it does not
provide a private right of action.
EU and UK News
Regulatory Updates
EFPIA Statement on the Use of AI in Medicines Under the
AI Act. On April 22, 2024, the European Federation of
Pharmaceutical Industries and Associations (EFPIA),
published a statement on the use of AI in the medicinal product
lifecycle in the context of the EU Artificial Intelligence
Regulation (AI Act).
EFPIA highlights the potential for AI to transform medicine
development, enabling faster, safer, and more effective treatments.
However, achieving this requires regulatory frameworks to be agile,
globally aligned, and tailored to the pharmaceutical industry's
needs.
EFPIA outlines five key considerations for governing AI in medicine
development:
1. The exception provided in the AI Act for scientific research and development should apply to AI-based development tools used in the research and development of medicines.
2. AI uses in medicine development cannot legally qualify as high risk under the AI Act as they do not meet the criteria for high-risk classification under the AI Act.
3. The existing legal framework for medicines is sufficiently flexible to create the right foundation to include AI uses in the development of medicines.
4. The European Medicine Agency's upcoming guidance on AI in medicine development will complement existing regulatory frameworks, ensuring responsible AI governance. (You can read about the draft in our July 2023 blog post.)
5. The ultimate goal for AI governance is to establish fit-for-purpose, risk-based oversight that considers the specific context of AI use in medicine development, balancing innovation with safety and ethical principles. EFPIA expressed its commitment to collaborating with regulatory bodies, patient groups, and other stakeholders to leverage AI's potential while upholding fundamental rights and safety standards.
Publication of the MHRA's Strategic Approach To AI. On April 30, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published its strategic approach to the regulation of AI. The publication is in response to the request from the Secretaries of State of the Department for Science, Innovation and Technology and the Department of Health and Social Care (DHSC) dated February 1, 2024, in which the MHRA was asked to provide details about what steps it is taking in accordance with the principles and expectations of the government's pro-innovation approach as set out in the white paper published in 2023.
The MHRA considers the opportunities and risks of AI from three different perspectives as follows:
1. As a regulator of medical devices utilizing AI
- The MHRA is the co-chair of the International Medical Devices Regulators Forum working group on AI- and machine learning-enabled medical devices to ensure global regulatory harmonization.
- Many AI products that are currently classified as low risk (class 1) will be up-classified to protect users.
- A pilot of the MHRA's AI-Airlock regulatory sandbox will launch in spring 2024. (This was launched on May 9, 2024, and will be discussed in our next digest; you can read more in our May 2024 blog post.)
- There will be "clear guidance" on cyber security for AI as a medical device (AIaMD) to be published in spring 2025.
- Existing guidance on applying human factors to medical devices will be supplemented by further detailed guidance specifically for AIaMD products in spring 2025.
- The new regulations will strengthen obligations on manufacturers, conformity assessment bodies, and the MHRA to ensure greater accountability and governance.
- Predetermined Change Control Plans will be introduced in the new regulations to better govern the full-life-cycle management of AIaMD products.
- Guidance has already been implemented, and there is new planned guidance including good machine learning practice for medical device development and best practice AIaMD development and deployment.
2. As a public service organization that can use AI to improve the efficiency of regulatory services
- The MHRA is exploring the use of supervised machine learning to conduct an initial quality assessment of applications and provide a score for each criterion.
- The MHRA is also developing an MHRA data strategy to use AI safely within its regulatory services, including the application of generative AI and large language models to real world data to understand the relationship between exposure to medical products and clinical outcomes, and the use of these methods in vigilance systems.
- The MHRA is developing a Medicines Website Checking tool for the public to report the advertisement of suspected illegal medicinal products.
3. As an organization that makes evidence-based decisions in relation to products and companies using AI to undertake their activities and generate evidence
The MHRA is collaborating with the pharmaceutical industry to understand their use of AI for vigilance purposes and to develop best practices for the use of AI. The MHRA anticipates that new medicines will be developed faster at lower costs and that clinical trial design will change, but is confident its regulatory pathways are "sufficiently agile and robust" to respond to such changes. You can read more in our May 2024 blog post.
Continued Global Collaboration on AI Safety.
The UK government continues to lead global efforts in ensuring AI
is safe and trustworthy. On April 2, 2024, the UK and U.S. governments announced signing a Memorandum of Understanding whereby the AI
Safety Institutes of the two countries will collaborate on
technical research in relation to AI safety, develop safety model
evaluations, and share guidance for AI safety with other
governments on international standards for AI safety testing. On
April 12, 2024, the UK and Republic of Korea announced that
planning was underway for the next global meeting on the safe
development of AI at the AI Seoul Summit on May 21-22, 2024. The AI
Seoul Summit follows the AI Safety Summit held in November 2023 at
Bletchley Park in the UK. Industry is expected to provide updates
on how they are fulfilling commitments made at Bletchley Park to
ensure the safety of AI technologies, and the first iteration of
the International Scientific Report on Advanced AI Safety is
expected to be released. Along with safety, the AI Seoul Summit
will also cover how the benefits and opportunities of AI can be
shared more fairly and how innovation can be further
advanced.
UK Government Seeks To Use AI in the NHS To Improve Patient
Care and Efficiency. On April 25, 2024, it was announced that the National Health Service of
England (NHS) and the Incubator for Artificial Intelligence (i.AI)
signed a partnership to support the use of AI in the NHS. i.AI is a
UK government organization made up of technical experts, which was
established under the direction of the Prime Minister to progress
AI capabilities within government. One of its main focuses is to
improve public services through AI applications. The new
partnership aims to identify opportunities where AI can improve
patient care and the speed of treatment and operational efficiency
within the NHS. This will be done through non-clinical AI
solutions, rather than through the development of new AI-based
medical devices.
Update to the UK Government's Medtech Strategy and
an Innovation Classification Framework. On April 9, 2024,
the DHSC published a report reflecting on its achievements over the
last year towards meeting the goals set out in the medical technology (medtech) strategy launched
in February 2023 and the next steps in boosting the adoption of
medtech within the NHS. The report is structured into the four
stages of the innovation pathway, which the government is seeking
to streamline:
1. Entry point, noting the launch of the
Innovative Devices Access Pathway pilot in September 2023 aimed at
bringing innovative technologies to the NHS where there is an unmet
medical need (discussed in our September 2023 blog post) and the
government's intentions in relation to an international
recognition pathway.
2. Approvals, noting expanded UK approved body
capacity from four to nine and continued work to reform the medical
devices regulatory framework in accordance with its roadmap published in January 2024.
3. Funding and commercial, noting a £30
million Health Technology Adoption and Acceleration Fund launched
in October 2023 to enable the NHS to invest in and implement
medtech.
4. Adoption, noting that to address health
inequalities and variation in the availability of effective medtech
across different NHS Trusts, the government has mandated NHS Trusts
to submit certain data by March 2024, which will be expanded later
in the year.
Also on April 9, 2024, the DHSC published a medical technology innovation classification
framework, which has been developed in consultation with
stakeholders across the medtech sector. This guidance aims to
provide assistance and clarity to industry on how innovation is
described and defined. The overarching definition for a device to
be described as an innovation is: "[the device] should
demonstrate an incremental improvement, be a novel application or
is a novel device that meets an unmet clinical need or provides
improvements upon existing technology or models of care. The device
can be scaled with the end-goal of benefiting the system, patients
and/or care providers." It provides criteria to assess whether
a medical technology is incremental, transformative, or disruptive,
with example case studies, as well as guidance, on how to explain
the innovative aspect of a device compared to what is already
available on the market. Annex A of the framework provides a useful
flowchart to assist industry in classifying their innovation.
MHRA Provides Updates on Regulatory Reform for Medical
Device Legislation in the UK. On April 25, 2024, the MHRA
published an update on various steps being
taken to reform the regulation of medical devices in the UK.
First, a meeting of the new International Medical Device Regulators
Forum in March progressed discussions on leveraging the
international recognition of assessments of devices made by the
competent authorities of countries with robust regulatory regimes
to improve patient access. At the meeting, it was agreed that the
Artificial Intelligence/Machine Learning-enabled working group,
which is co-chaired by the MHRA and FDA, will develop a document on
AI lifecycle management. The MHRA will also co-chair a working
group focused on updating the documents on clinical evidence for In
Vitro Diagnostics (IVDs).
Second, the MHRA has continued to develop its own international
recognition framework and published a statement of policy intent on May 21, 2024. To
assist, the MHRA has been collaborating with four multinational
companies who have products approved by the FDA, but not regulators
in the UK or EU. The MHRA has called for smaller companies with
products encompassing software as a medical device or IVDs and are
interested in accessing the UK market after first launching in
another country to come forward. (This will be discussed in our
next digest; you can read more in our May 2024 blog post).
Finally, the MHRA notes that it remains on track to meet the milestones set out in its roadmap for the future regulatory framework for medical devices. In keeping with the milestones, the new regulations for post-market surveillance will be brought before Parliament soon, the stakeholder engagement for the sessions for the future core regulations will be held in June and July, and the AI Airlock (the regulatory sandbox for AI medical devices) will be launched in the coming weeks. (This has now been launched, and will be discussed in our next digest; you can read more in our May 2024 blog post.)
Privacy Updates
European Parliament Formally Adopts Agreement on the
EHDS Regulation. On April 24, 2024, the plenary of the
European Parliament formally adopted the agreement reached on
March 15, 2024 with the European Council on the regulation creating
a European Health Data Space (EHDS) Regulation (EHDS Regulation).
As we have discussed in previous digests, the EHDS will create a
framework that will provide governance and infrastructure for the
use of electronic health data. On the same date, the European
Commission published a Questions & Answers document on the EHDS
Regulation, where it stresses the importance for the industry to
use the health data contained in the EHDS to foster innovation that
will improve disease prevention, diagnosis, and treatment.
The agreement on the EHDS Regulation now needs to be adopted by the
European Council, which is expected to be published in the EU
Official Journal in autumn, and the EHDS is expected to become
operational in 2028.
New Guidance From the ICO on Transparency in Relation to
Health and Social Data. On April 15, 2024, the Information
Commissioner's Office (ICO) published new guidance to assist health and
social care organizations, as well as private organizations that
use health and social care information, be transparent with
patients about how and why their personal health information is
being used. The guidance sets out what data protection transparency
means in relation to Article 5(1) of the UK General Data Protection
Regulation and provides a helpful checklist on how to assess if an
organization is being transparent. Compliance with the checklist
should be reviewed at regular intervals. Practical steps are also
set out to assist organizations in the development of effective
transparency, for example suggesting ways to demonstrate that the
organization is being open and honest, providing a choice to
patients on how their data is used, and engaging with patient
groups to better understand if the proposals sufficiently address
concerns. The guidance also sets out factors to consider in
effectively informing patients about steps taken to ensure
transparency, for example the directness of the communication,
communication methods, and presenting information in an easily
accessible manner that avoids "information overload." The
guidance supplements other ICO guidance on the principle of transparency and the right to be informed.
Reimbursement Updates
Publication of New Pricing Structure for the
Reimbursement of Digital Medical Devices in France. In
early 2023, and as discussed in our March 2023 digest, France created an
accelerated market access pathway for innovative digital
therapeutic medical devices, known as PECAN. Manufacturers can use
the PECAN scheme for digital medical devices for therapeutic
purposes which are not yet eligible for reimbursement, but which
are presumed to be innovative in terms of clinical benefit or
progress in the organization of care. Companies, therefore, can use
this one-year scheme while finalizing their application for
reimbursement under the regular scheme, provided a doctor
prescribes the digital medical device to the patient.
Companies eligible to apply for this scheme must:
- Have a valid CE marking
- Be presumed to be innovative and be able to provide data supporting clinical benefits
- Comply with interoperability and security frameworks established by the Digital Health Agency to guarantee the exchange, sharing, security, and confidentiality of patient health data
Following submission of the application, the Digital Health Agency and the French National Authority for Health will assess the application and the relevant decision will be taken.
Up to now, the reimbursement rate for digital technologies (rather than remote monitoring products) has not been set, meaning up-take has been low. The Order of April 22, 2024 introduces the new pricing structure for PECAN, setting out the reimbursement amounts for companies making available digital medical devices for therapeutic purposes. These amounts are:
- An initial lump sum of €435 including tax, per patient, for a period not exceeding three months
- A monthly rate of €38.3 including tax, per patient
- A maximum amount of financial compensation of €780 including tax per year, per patient
This is an important step in ensuring digital therapeutic products can be widely available in France and ensuring developers can obtain reimbursement for these products.
IP Updates
Inadvertent IP Infringement Via Online Targeting to UK
Customers. A recent UK Supreme Court judgment (Lifestyle
Equities v. Amazon) and a subsequent High Court judgment (Merck v. MSD)
have highlighted the potential risk of incidental trademark
infringement through online targeting to UK customers. This is
relevant to readers of this digest because the provision of virtual
health services and the online sales of digital health products
could inadvertently be deemed an act of targeting to UK customers
and amount to an infringement of trademark rights.
Whether online activities are targeted at the UK needs to be viewed
objectively from the perspective of the average consumer of the
relevant goods or services who is deemed to be reasonably
well-informed and reasonably observant and circumspect. A business
"should be treated as having used a mark in the UK if it has
itself 'pushed' its business and mark into the UK, not if
it has been 'pulled' into the UK by (for example) its
customers abroad, even though they may be based in the UK."
The inquiry on targeting is highly fact sensitive. The judge's
approach in Merck v. MSD shows that targeting should take
into account the entirety of a website (or other online media) and
the impact it has on the consumer.
In Merck v. MSD, the judge's systematic approach of
reviewing evidence relating to each alleged incident of
infringement provides helpful guidance. One example of infringing
use related to tweets sent by MSD containing "MERCK" in
an "MSD" branded environment. Such tweets were considered
to convey a message to UK consumers that MSD was entitled to use
"MERCK" in connection with its goods and services in the
UK.
The decision confirms that use of signs on digital platforms, while
not designed exclusively for a UK audience, can still lead to
parties falling foul of UK trademark law if the overall message
tells consumers the relevant entity is entitled to use the mark in
relation to their goods and services, even if used in a promotional
capacity.
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