Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital health. We plan to issue Vital Signs near the beginning of each quarter to cut through all the noise and provide access to a curated resource on "must know" legal and regulatory topics impacting digital health.
As you will see in this first issue, our team of contributors from around the globe culled through various information across legal specialty areas (cybersecurity, health regulatory, IP, litigation, tax, and transactional) to present complex issues in a user-friendly fashion. Hot links to underlying legal and regulatory materials are included within each section, enabling Vital Signs to serve as your ongoing quick reference for all the notable recent legal and regulatory materials.
In this issue, we start with "Industry Insights"—dedicated in each issue to an overarching topic of industry interest—covering the evolving nature of how disparate industry stakeholders are advancing their vision, collaboration, and utilization of digital health, especially in the decade ahead. You'll also learn about: (i) U.S. federal efforts focused on streamlining FDA's digital health approach and advancing Medicare's telehealth reimbursement, while enforcement attention and methods evolve; (ii) U.S. states' legislative attention around telehealth and data privacy; (iii) Europe's flurry of digital health policy covering privacy, cross-border services, device development, and interoperability; (iv) Mexico's adoption of a novel tax on digital intermediaries supporting telemedicine; and (v) Japan's adoption of significant modifications to its Pharmaceuticals and Medical Devices Act.
Worlds Colliding—A New Decade for Digital Health
Over the past decade, unprecedented advances in technology and know-how have resulted in an ever-expanding and diversified "digital health" universe. From the growing use of communication technologies to deliver clinical care, to the rise in fitness and healthy living apps, to improvements in diagnostic medical devices, digital innovation has increasingly defined many of our health care experiences over the past 10 years. As we enter a new decade, it is certain this trend will continue.
We expect the next 10 years, however, to encompass something more than continued vertical growth. If the last decade was defined by innovation and forward advancement in numerous yet siloed sectors of the health care industry, the next decade is likely to be defined by horizontal growth—a growing overlap in disparate digital health worlds to create one, integrated digital health ecosystem. We began to see some of this overlap at the tail end of the 2010s.
For example, traditional telehealth services are starting to incorporate medical devices (particularly diagnostic and triaging software) as part of patient-facing platforms. Software has long been used for administrative functions in health care settings. In the last few years, however, we began to see new types of clinical decision support ("CDS") software being utilized for things like patient screening, as well as for assisting providers in identifying the most appropriate treatment plan for a patient's disease or condition. To date, these functionalities have been relatively simplistic, but with the rise of machine-learning algorithms and AI, it seems certain that more sophisticated medical software will soon be upon us. We anticipate that CDS software will become a ubiquitous and indispensable aspect of patient care in the 2020s.
Digital health is also being utilized to bring therapies to market. Sponsors of clinical trials increasingly use digital means, such as data mining through claims and electronic health records, to more rapidly and comprehensively identify, recruit, and engage with clinical trial participants. The use of wearable technologies has also improved the means of collecting and transmitting clinical data to trial investigators. Together with the more traditional means of communicating patient reported outcomes, the use of data from wearables enhances a sponsor's ability to demonstrate the achievement of applicable clinical trial endpoints. In addition, technological advances are being further deployed to support the development of "decentralized" or "virtual" clinical trial protocols, in which an increasing percentage of trial procedures are administered from a patient's home or other remote locations.
The promise of digital health in each of these contexts is significant. These developments could result in less expense, more expedient and more accurate outcomes, and better engagement with subjects, patients, and consumers. But these developments, of course, also give rise to attendant practical and legal challenges, particularly given the different rules and regulators involved. For example, the use of sophisticated medical software and data mining gives rise to privacy and security concerns and may require the use of special informed consents. Likewise, while clinical trials are typically regulated at the federal level, the rise in "virtual" clinical trial protocols may require careful consideration of state telehealth and practice of medicine rules. While the development of technology invariably lurches ahead of regulation, all stakeholders will need to work together to advocate for continued evolution of the regulatory process to allow for a responsible deployment of innovative technologies to improve patient care.
UNITED STATES DEVELOPMENTS
FDA Proposes New Guidance on Clinical Decision Support ("CDS") Software
In 2016, the 21st Century Cures Act ("Cures Act") explicitly excluded CDS software from FDA regulatory authority. Due to the impressive diversity of digital products that provide some type of clinical decision support (including many that incorporate artificial intelligence and machine learning algorithms), industry stakeholders have since grappled with significant uncertainty about whether certain applications might qualify as CDS software or, alternatively, fall under FDA's regulatory authority. FDA initially issued draft guidance in 2017 to help resolve some of this uncertainty but later withdrew that draft guidance in response to public feedback. FDA recently issued new draft guidance in September 2019 to again address the lingering uncertainty. The September 2019 draft guidance identifies three distinct categories of software: (i) that which meets the Cures Act definition of "CDS software" and, therefore, falls outside of FDA regulatory authority; (ii) that which falls under FDA's regulatory authority but over which FDA intends to exercise "enforcement discretion" due to the lower risk of the applications; and (iii) that which falls under FDA's regulatory authority and over which FDA intends to focus its regulatory oversight. Industry should closely monitor FDA's oversight activities with regard to CDS software in 2020 to gain further insight into FDA's interpretation of its regulatory reach.
FDA Modernizes Regulations to Facilitate Utilization of Digital Technologies in Clinical Trials
In 2019, FDA continued its initiatives focused on modernizing the clinical trial process by issuing numerous draft and final industry guidance supporting the use of adaptive and complex innovative trial designs, novel trial endpoints and enrichment strategies, and duly qualified biomarkers and other drug development tools. Certain of these initiatives are pursuant to mandates under the Cures Act and incorporate evolving technologies such as complex algorithms and digital tools. FDA also recently articulated policies intended to provide patients with a more pronounced voice in clinical investigation design and to permit industry to mine and utilize certain real-world evidence in the drug development process. FDA provides additional information regarding real-world evidence and patient engagement on its website.
Proposed CONNECT Act Transfers Telehealth Reimbursement Eligibility Decisions to Regulators
The CONNECT for Health Act of 2019 ("CONNECT Act") was introduced into the U.S. Congress House and Senate in October 2019. If adopted, the Connect Act could significantly expand reimbursement for telehealth services provided to Medicare beneficiaries. Specifically, the CONNECT Act would empower the U.S. Department of Health and Human Services ("HHS") to waive the specific geographic, modality, provider type, and other limitations currently in effect under §1834(m) of the Social Security Act. HHS may grant such waivers where proposed outlays: (i) reduce spending without reducing quality; (ii) improve quality without increasing spending; or (iii) serve health shortage areas. The CONNECT Act would also eliminate the rural geographic limitation for tele-mental health services and tele-specialist consultations in the emergency department, all §1834 limitations for hospice recertifications following an in-person visit, and the originating site limitation for certain Indian Health Service and Native Hawaiian Health Care facilities.
Federal Criminal and Civil Investigations Touch on Digital Health Industry
Two major criminal investigations by the FBI, HHS-OIG, and DOJ involved the digital health industry in 2019: Operation "Double Helix" and the related Operation "Brace Yourself." These investigations were unprecedented in the digital space for their size and scope. Operation Double Helix involved $2.1 billion in alleged losses resulting from fraudulent billing of genetic tests, orthotic braces, and pain creams. Notably, CMS issued its own press release highlighting its involvement in this enforcement activity through the Center for Program Integrity, publicly flexing its enforcement muscle. Operation Brace Yourself involved $1.2 billion in alleged telemedicine fraud among companies that sell durable medical equipment ("DME") across the country. Charges were brought against at least 24 defendants including corporate entities, health care providers, and corporate executives, and they involved allegations of commercial/nongovernment program fraud in addition to federal program fraud. These investigations, along with the HealthRight investigation announced in 2018, highlight the government's continuing focus on areas of long-standing concern (compound drugs, DME, and lab testing), but in the digital space.
Government civil enforcement activity in the digital health space appears to be on the uptick, with a continued focus on compounding prescriptions reimbursed by TRICARE and enforcement against electronic health record ("EHR") companies. Diabetic Care Rx LLC, two executives, and private equity firm Riordan, Lewis & Haden Inc. settled a qui tam lawsuit for $21.36 million in September 2019, following up on the DOJ's intervention decision in early 2018. In February 2019, EHR vendor Greenway Health LLC entered into a settlement for $57 million that the DOJ independently pursued, and a few months later IBM and Cúram Software entered into a settlement for $14.8 million related to misrepresentations made during the development of Maryland's Health Insurance exchange website and IT platform.
Proposed Stark and Anti-Kickback Regulatory Reforms Notable for Potential Broad Health Industry Implications
In October 2019, OIG and CMS published large packages of proposed reforms to modernize the regulations that interpret the federal Anti-Kickback Statute and the federal Stark Law, respectively. Jones Day is in the process of publishing a series of Commentaries to summarize the more significant proposals within the packages. Though only a narrow set of the proposed reforms specifically impact the digital health industry, all proposed reforms impact the health care space generally and may have implications for various digital health initiatives. See our Commentaries on the New Exception for Dialysis-Related Telehealth Technologies, Changes to Valuation Terms Under the Federal Stark Law, and Newly Proposed Protections for Cybersecurity Technology Under the AKS and Stark Law.
Express Scripts Unveils Stand-Alone Digital Health Formulary
Express Scripts, one of the nation's largest pharmacy benefit managers, unveiled the industry's first stand-alone digital health "formulary" in December 2019. The initial cohort of digital health solutions on the formulary are designed to aid in the management of common chronic conditions, including diabetes, hypertension, asthma, and depression. This initial cohort includes specific "preferred" and "alternative" vendors for each of these various chronic conditions, with solutions that engage with patients in a variety of ways (e.g., remote monitoring of a patient's use of a drug therapy, synching a diagnostic device to provide vital information to patients and alert them of potential concerns, virtual personal coaching from a health or wellness professional, and virtual support from a patient's peer). A team of physicians, pharmacists, and experts in health research assisted Express Scripts in developing the formulary, with the goal of ensuring that each digital health solution on the formulary is cost-effective, demonstrates therapeutic value, and meets privacy and security standards. In an era where digital health solutions are rapidly expanding and the global digital health market is expected to reach a valuation of more than $234 billion in 2023, the Express Scripts digital health formulary seeks to: (i) provide patients with greater access to validated digital health solutions for their chronic conditions; (ii) reduce the administrative burden for plan sponsors in contracting with digital health companies; and (iii) provide a pathway for digital health companies to get their products covered and to patients.
California Embraces Telehealth with Clarifying Legislation and Medi-Cal Updates
Several recently adopted changes to California law and Medi-Cal policies signal California's expansive acceptance of telehealth as a means of delivering health care services. For example, departing from laws and regulations in many other states that explicitly exclude "questionnaires" from the definition of "telehealth," AB 1264, signed into law in October 2019, specifically recognizes self-screening tools and questionnaires as a legitimate modality for delivering telehealth services and prescribing medications via telemedicine as long as the standard of care is met. The California Department of Health Care Services ("DHCS") also revised its Medi-Cal telehealth policy (retroactively effective as of July 1, 2019) to expand reimbursement for telehealth services provided to Medi-Cal beneficiaries. Specifically, the revisions grant health care providers broad discretion to determine the clinical appropriateness of delivering particular services via synchronous or asynchronous telehealth modalities. Any health care service may now be delivered by any modality as long as the standard of care is met, and the service is a covered benefit under Medi-Cal. Finally, the California Assembly passed California's telehealth private payer parity law in October 2019, AB 744, to join a majority of states in mandating that health insurers and health care service plans cover telehealth services on the same basis to the same extent, and at the same rate, as in-person services. The law does not limit the ability of a health insurer or plan and a health care provider to negotiate the rate of reimbursement for a health care service, but it forbids insurers from limiting coverage to select third-party corporate telehealth partners. Finally, legislation adopted in October 2019, AB 1494, requires DHCS to reimburse certain community clinics for providing telephonic or telehealth services to Medi-Cal beneficiaries during, or immediately following, a state of emergency.
Florida Telehealth Law Offers New Registration Option for Out-of-State Health Care Providers
Florida's new telehealth law—which went into effect on July 1, 2019, and establishes statutory standards of practice for the provision of telehealth in the state—includes a mechanism for certain out-of-state health care providers who do not plan to open a Florida office, do not provide in-person health care services to Florida patients, or do not already possess a Florida license to provide telehealth services in Florida. Specifically, these out-of-state providers (including physicians, physician assistants, nurse practitioners, nurses, dentists, and other health care providers) are eligible to deliver telehealth services to patients in Florida if they register with the applicable board or the Florida Department of Health and satisfy certain requirements, including, among other things, maintenance of professional liability coverage for telehealth services, designation of a registered agent located in the state, and compliance with certain disciplinary requirements. Out-of-state practitioners with a website must also "prominently display" a hyperlink to the Florida Department of Health's website, which will contain information about each registered provider, such as specialties, board certifications, and malpractice insurance carriers and policy limits. Although the Florida Department of Health has not yet issued regulations implementing the new telehealth law, it has published FAQs.
Out-of-state health care providers that choose not to utilize the new registration option may still obtain authorization to provide telehealth services to Florida patients through the more traditional route of full licensure. Notably, while Florida has joined the enhanced Nurse Licensure Compact, it has yet to become a member of the Interstate Medical Licensure Compact, which offers an expedited pathway to full licensure in multiple states. Florida just recently proposed legislation to adopt the Compact in January 2020.
Georgia Supreme Court Allows Class Action Complaint Against Health Care Provider Arising from Data Breach
On December 23, 2019, the Georgia Supreme Court, in a case of first impression, reversed the Georgia Court of Appeals' affirmance of the dismissal of plaintiffs' data breach claims arising from hackers accessing the protected health information of at least 200,000 current and former patients of an orthopedic clinic. The Georgia Supreme Court distinguished prior Court of Appeals decisions rejecting data breach claims for lack of injury, on the grounds that those cases did not involve a criminal illegally accessing the protected information and requesting a ransom payment for that data. Under those circumstances, the court held that plaintiffs "were much further along the chain of inferences" necessary to allege a probable injury. The Supreme Court's analysis may breathe new life into data breach claims against Georgia health care providers, especially if they involve a hacker requesting a ransom for the stolen data.
Maryland Med Board Regulations Impose New Modality Requirements for Telehealth
In August 2019, the Maryland Board of Physicians revised its telehealth regulations to implement a number of changes, including new defined terms and new practice standards regarding patient and provider identification, informed consent, and privacy and security. Most notably, the new regulations provide that a physician must perform a "synchronous, audio-visual" patient evaluation to establish a physician–patient relationship, prior to providing treatment or prescribing medication. This is a departure from the prior regulations, which provided that a physician–patient relationship could also be established through "real-time auditory communications."
New York SHIELD Act Broadens New York Data Security and Breach Reporting Requirements
On October 23, 2019, New York passed the Stop Hacks and Improve Electronic Data Security Act ("SHIELD Act"). The SHIELD Act broadened New York data security and data breach reporting requirements by: (i) expanding the definition of "data breach" to include mere "access to" (rather than affirmative "acquisition of") certain computerized private information; (ii) broadening the definition of "private information" to include biometric information, financial accounts, and username or email address in combination with a password or security question; (iii) expanding the law's jurisdictional reach to any company that owns or licenses private information of a New York resident (even if a business does not conduct business in New York); (iv) increasing civil penalties for violations of the law; and (v) lengthening the statute of limitations. Additionally, effective on March 21, 2020, the SHIELD Act will require companies that own or license private information of a New York resident to implement certain data security protections, including provisions addressing risk assessments, employee training, service provider contract requirements, and data disposal. Importantly, the SHIELD Act imposes certain data security and breach reporting obligations on companies that are regulated under HIPAA, as well as companies that are active in the health care space but not otherwise regulated under HIPAA.
Washington State Telehealth Collaborative to Make Available Online Telemedicine Training
Pursuant to a law passed last year, Washington is requiring the Washington State Telehealth Collaborative to publish an online telemedicine training module for health care professionals beginning January 1, 2020. Participation in the training is currently voluntary. The training is required to include information on current state and federal law, liability, informed consent, and other criteria established by the collaborative for the advancement of telemedicine, in collaboration with the Washington Department of Health and the Washington Medical Quality Assurance Commission. A video training published in 2019 is currently available on the Washington State Telemedicine Collaborative website.
Multiple Advances for Electronic Health Records and Digital Health Interoperability
On February 6, 2019, the European Commission adopted Recommendation (EU) 2019/243 (available in English), which sets out a framework for the development of an EU electronic health record exchange format to enable the secure, interoperable, and cross-border access to and exchange of electronic health data. The framework includes a series of principles on access and exchange of electronic health records and a set of common technical specifications, and it encourages Member States to ensure secure access to electronic health record systems at the national level.
On July 10, 2019, MedTech Europe—the European trade association representing the medical technology industries—released a position paper welcoming the European Commission's Recommendation and calling on European health authorities, payers, and procurers to "engage and contribute to an interoperable data ecosystem" (available in English). MedTech Europe also asked for more public investment in digital health infrastructures, including electronic health record systems, and requested the European Union to provide economic resources for this purpose.
On June 12, 2019 the eHealth Network—a network set up under Article 14 of Directive 2011/24/EU and composed of members of EU national authorities responsible for eHealth—adopted a document providing "Guidelines on an interoperable eco-system for digital health and investment programmes for a new/updated generation of digital infrastructure in Europe" (available in English). The document aims to guide the European Commission, Member States, and industry toward funding and purchasing choices that foster interoperability in digital health.
Increased Cross-Border Options for Prescriptions and Health Services
On January 24, 2019, Finland and Estonia became the first EU Member States to be able to exchange ePrescriptions cross-border. Since then, more than 1,000 Finnish citizens have been able to go to a pharmacy in Estonia and retrieve medicines prescribed electronically by their doctors in Finland (further information is available in English). Croatia similarly started accepting ePrescriptions from Finland on June 17, 2019, thanks to "MyHealth @European Union," the electronic cross-border health services in Europe (further information is available in English).
On June 24, 2019, Luxembourg and the Czech Republic launched the first cross-border eHealth service: "eSanté." This service enables the electronic exchange of patient summaries between European countries (starting with Luxembourg-Czech Republic transfers, with the aim of expanding to all EU Member States participating in the European program Connecting Europe Facility—eHealth Digital Services Infrastructure) (further information is available in French and in English). Since September 24, 2019, Croatia has similarly been able to receive patient summaries from incoming travelers from the Czech Republic, making it possible for Czech citizens to access their health data in case of an emergency in Croatia (further information is available in English).
New Guidelines Issued Regarding Software as a Medical Device
On October 11, 2019, the European Commission issued guidelines regarding software under the new EU Regulations on medical devices: "Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745–MDR and Regulation (EU) 2017/746–IVDR" (available in English). The Guidance provides manufacturers with useful guidance on both qualification (i.e., when a software is considered to be a medical device) and classification (under which category the product falls depending on the risk of harm the device poses to patients (Class I, IIa, IIb, or III)). The Guidance contains a list of examples of software currently used in the health care industry that qualify as medical devices. The document also clarifies the rules on classification laid down in the new EU Regulations. Finally, the Guidance underlines the importance of gathering solid clinical evidence in order to support devices' claims, as well as collecting post-market data for demonstrating software's efficacy and safety over time.
New Guidance Available Regarding the Cybersecurity of Medical Devices
In December 2019, the Medical Device Coordination Group—a group composed of representatives of all Member States and chaired by a representative of the European Commission—adopted a new document "Guidance on Cybersecurity for medical devices" (available in English). The document provides assistance to manufacturers regarding how to meet the cybersecurity requirements of Annex I to the new Medical Device (available in English) and In-Vitro Medical Device Regulations (available in English), to ensure that devices are protected against unauthorized access.
ENISA Issues a Status Report on Incident Response Development
In November 2019, the European Union Agency for Cybersecurity ("ENISA") issued a report on the status of EU Member States incident response development. The report provides an analysis of the current operational Incident Response setup within the Directive on Security of Network and Information Systems sectors, including the health care sector.
Data Security Enforcement Impacts Health Industry in Multiple EU Countries
In December 2019, the German data protection authority fined a hospital €105,000 for lack of appropriate technical and organizational controls in the management of patient-related personal data. Similarly, in November 2019, the Dutch data protection authority fined a medical insurer €50,000 for lack of appropriate technical and organizational controls in the management of personal patient data.
Belgium FAMHP Launces PharmaStatut
On December 6, 2019, the Federal Agency for Medicines and Health Products ("FAMHP") launched "PharmaStatut," a new online application that collects and publishes information on the availability of medicines in Belgium. Such up-to-date information is intended to help patients, doctors, pharmacists, and the pharmaceutical industry in mitigating the impact of unavailable medicines (more information is available in English).
France Adopts Broad Telehealth Law Expanding Scope of Practice
On July 24, 2019, France passed a law that broadened the scope of telehealth and eHealth options in the country (available in French). For example, under the new law, the section of the Public Health Code previously dedicated to "telemedicine" has been retitled "telehealth." Previously, the use of the term "medicine" pointed only to "medical" professions recognized by French law, i.e., doctors, dentists, and midwives. The new use of the term "health" includes a much broader scope of health professionals, such as nurses, pharmacists, and chiropractors, authorizing such health professionals to utilize information and communication technologies in their practice. In addition, under the law, telehealth activities may now be reimbursed in certain circumstances. Specifically, telehealth services may be covered if provided following an initial, face-to-face meeting between the patient and a health professional of the same profession as the one providing the telehealth services (additional information available in French). An implementation decree is expected to be adopted in the next few months to provide a list of authorized telehealth activities. These changes are expected to enable nurses to provide up to 250,000 additional services per year and chiropractors to provide up to 400,000 additional services. Moreover, the law paves the way for health professionals from other European Member States to offer telehealth services to French patients, under the framework of Directive 2005/36/EC on recognition of professional qualifications and Directive 2011/24/UE on the application of patients' rights in cross-border health care.
Germany Statutory Health System Provides Reimbursement Coverage for Care Delivered Through Digital Health Apps
In December 2019, Germany adopted cohesive legislation dedicated to providing reimbursement for care delivered through digital health apps. The legislation opens market access for care delivered through digital health apps to 72 million patients covered by Germany's statutory health care system (and could potentially extend to the entire German population, as the private insurance companies are expected to follow suit). The legislation provides for a two-step process. First, the digital health app must meet the legislative requirements for coverage, which includes digital health apps that: (i) are registered with the German regulator, BfArM, as a Class I or Class IIa software-as-a-medical device (Class IIb and Class III devices are not covered); and (ii) have demonstrated a positive effect on health care outcomes. Once the digital health app meets such requirements, any doctor in Germany may prescribe the digital health app, which will be reimbursed at the manufacturer's asking price. As the second step in the two-step process, the manufacturer will be required to negotiate the reimbursement price, within a year of launch, with the umbrella organization of the German public payors. Various technical and procedural details will be set forth in an upcoming regulation of the German Ministry of Health.
Norway Signs Cross-Border Genomic Database Initiative
On June 14, 2019, Norway signed the 2018 Declaration on genomics cooperation: "Towards access to at least 1 Million Genomes in the EU by 2022," joining 20 other countries in this initiative to link genomic databases across borders. Other states that have joined the initiative include Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, and the United Kingdom.
Mexico VAT Law Could Tax Digital Platforms
Effective June 2020, Mexico approved a group of reforms to its Value Added Tax ("VAT") Law (available in Spanish) that could tax some services of digital platforms that serve as intermediaries between medical service providers and patients residing in Mexico. Specifically, digital intermediary services (i.e., the intercommunication services) may be taxed under Mexican VAT even though medical services (i.e., the medical professional advice) are VAT exempt. Telemedicine service providers located in countries other than Mexico should carefully review contractual relationships with the platforms that provide digital intermediary services to identify whether or not they would be affected by this new tax provision.
Chinese National Health Commission's Measures on Printing and Distributing National Health and Medical Big Data Standards, Security, and Service Administration Measures
The Chinese National Health Commission recently issued National Health and Medical Big Data Standards, Security, and Service Administration Measures ("Measures") (available in Chinese). The Measures: (i) establish a definition for "big data" in the health care context; (ii) outline the boundaries and powers of national and local health administrative departments; and (iii) describe the responsibilities and rights of health institutions and corresponding enterprises and public institutions, among other topics. In light of these Measures, health industry enterprises in China should identify and evaluate their health and medical big data from various aspects, such as the source of data, the safety of data storage, the use and transfer process, and the privacy of personal data.
Japan Amends Pharmaceuticals and Medical Devices Act Authorizing a New Marketing Approval Process for AI-Enabled Medical Devices
Japan amended its Pharmaceuticals and Medical Devices Act on November 17, 2019. In general, the expansive amendments improve regulations covering product development to post-marketing of pharmaceuticals, medical devices, and regenerative medicine products in order to approve those products more safely, quickly and efficiently. Specifically, the amendments provide for a new marketing approval system designed for medical devices that are anticipated to undergo continuous improvement in response to technological innovations (e.g., devices utilizing artificial intelligence). More information and other news is available in the Japan Legal Update.