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Global | Publication | March 2025
Norton Rose Fulbright lawyers Roger Kuan, Jason Novak, Apurv Gaurav, Bernard O'Shea, Rohan Sridhar, Véronique Barry, Vanessa Grant, Manpreet Singh and Sarah Pennington contributed several chapters to Digital Health 2025 International Comparative Legal Guide, published by ICLG, which is a leading global platform for legal reference, analysis and news. Kuan also served as a contributing editor for the publication.
Authors: Roger Kuan, Norton Rose Fulbright and David Wallace, Johnson & Johnson
The digital health sector experienced explosive growth even before the COVID-19 pandemic accelerated its adoption by mainstream payors, providers and patients. With the continued rapid pace of change in digital health, the expectation is that the delivery of healthcare will continue to transform. Within this transformation there will be some common themes.
The ability to gather data, generate clinical insights and transform those insights into actionable clinical solution(s) will form the foundation of value creation within digital health. In this paradigm, data access becomes the new “oil rush” as data will fuel the analytics engines behind many future digital health solutions. As a result, traditional technology players may create substantial competition for traditional healthcare providers. It remains to be seen whether those advantages will translate to success in the digital health marketplace.
Clinical adoption of digital health solutions will continue to be a challenge as there are significant clinician concerns about how to safely integrate these solutions into their day-to-day practice. Moreover, digital health companies must navigate the myriad of state and federal regulations/laws relating to data privacy, FDA regulatory, practice of medicine, and medical reimbursement in order for their solutions to even be accessible by clinicians in the first place.
Lastly, there are brewing geopolitical factors that may impact how well digital health companies succeed in the marketplace. Regional regulations on health data access and usage (e.g., General Data Protection Regulation, HIPAA, CCPA, etc.), reimbursement, and product approval are additional requirements to contend with for companies that are foreign to the jurisdiction. Also, many countries have begun to aggressively invest in the gathering of healthcare data (especially whole genome data) on a national level, which can potentially be leveraged to give domestic companies an edge over foreign ones. Examples of this are the UK Biobank Whole Genome Sequencing Project and Beijing Genome Institute (BGI) Million Chinese Genome Project. It is conceivable (and likely) that the UK and China will implement data-access policies that specifically benefit domestic digital health companies to give them a home-grown advantage.
Authors: Jason Novak and Q. Andy Guo Norton Rose Fulbright and Dr. Milad Alucozai, Revalia Bio
The healthcare and biotech industry is on the brink of a data-driven revolution, with artificial intelligence (AI) poised to transform drug discovery, personalised medicine, and healthcare delivery. However, this revolution brings a new array of data ownership, privacy, and security challenges. The following addresses these critical questions, exploring how biotech companies can navigate this complex landscape while safeguarding their intellectual property, driving innovation, and fostering trust. This discussion will examine strategies for balancing open collaboration with strong IP protection, ensuring data privacy and security, developing explainable and reliable AI, navigating regulatory uncertainties, and managing the risks tied to AI-driven healthcare solutions. Ultimately, it will underscore the essential role of leadership in cultivating a data-driven culture that views data as a strategic asset and encourages employees to use it responsibly to advance the healthcare and biotech industry.
Authors: Bernard O’Shea and Rohan Sridhar
In Australia, digital health is an umbrella term referring to a range of technologies that can be used to treat, diagnose and monitor patients and collect and share a person’s health information.
Similar to other jurisdictions, the term “digital health” is still developing as technologies evolve. At one end of the spectrum, the term includes the delivery of telehealth services, while at the other end, the term connotes mobile apps and software as a medical device (SaMD) used to deliver personalized and individualized medicine, with digital medical devices lying somewhere in between. The Therapeutic Goods Administration (‘TGA’) has also highlighted what they term Digital Therapeutics, which they characterise as being health software intended to treat or alleviate a disease, disorder, condition or injury, that works by generating and delivering a medical intervention that has a demonstrated positive impact on a patient’s health. This can stretch to companion ‘apps’ that are an adjunct to other treatments.
While digital health is not a defined legislative term, the Government has taken steps to define telehealth in order to include these services under the subsidised Medicare arrangement during the COVID-19 pandemic, and the national regulator, the TGA, regulates some digital health technologies as medical devices.
The key emerging digital health technologies in Australia are:
Authors: Vanessa Grant, Véronique Barry, Sarah Pennington, Manpreet Singh
In Canada, digital health is defined as health technologies that improve access to healthcare information, facilitate diagnosis and treatment, and improve patient access to care. More specifically, “digital health” may be defined as data-driven healthcare solutions and individualised delivery of therapeutics and treatments to patients using information technologies that enable seamless integration and communication between patients, healthcare providers, and others supporting healthcare systems.
Digital health technologies include stand-alone software applications, integrated hardware and software platforms, and medical devices (MDs) that include software and artificial intelligence (AI).
The key emerging digital health technologies in Canada are:
Authors: Roger Kuan, Jason Novak and Apurv Gaurav Norton Rose Fulbright
In the United States, digital health is a technology sector that is a convergence of high technology with healthcare. The result is a highly personalised healthcare system that is focused on data-driven healthcare solutions, individualised delivery of therapeutics and treatments to patients powered by information technologies that enable seamless integration and communication between patients, providers, payors, researchers and health information depositories.
The key emerging digital health technologies in the United States are:
Publication
The SFO’s Business Plan for 2025-2026 signals its intention to take centre stage in global financial crime enforcement, setting out its vision to be a “proactive, authoritative player in the global and domestic justice system”.
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On 16 January 2025, the USTR published a notice of determination that China’s targeting of the maritime, logistics and shipbuilding sectors for dominance is actionable under Section 301 of the US Trade Act of 1974. Section 301 grants the USTR the authority to investigate and remediate, including through the imposition of tariffs or other import restrictions, foreign trade practices that it determines (1) are unreasonable or discriminatory, and (2) burdens or restricts US commerce.
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The OECD Pillar Two rules (also known as the Global Minimum Tax), where implemented by a national jurisdiction, require multinational enterprises (MNEs) with a consolidated group turnover of more than €750 million to calculate the effective tax rate in each jurisdiction in which it operates.
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