Digital HealthAs the industry forges ahead to advance the digital
health ecosystem, the companies in this space will
navigate a complex set of business and legal issues thatare often evolving in real time. That's where Hogan
Lovells can help.
Our cross-jurisdictional team of more than 50 life
sciences lawyers bring a real-world sensibility to yourchallenges and business opportunities. We take atechnology-based approach to counseling on digital
health products and services and provide strategic
guidance on how to leverage opportunities for growth,minimize legal barriers, comply with rules, protect yourdata, and realize its value.
We advise at the cutting edge of technology withexpertise in areas such as artificial intelligence, big data,
blockchain, cybersecurity, use of consumer grade
wearables, digital therapies, virtual clinical trials, andtelehealth by bringing together our experience frommany angles of our life sciences practice. Moreover, wepull experience from our colleagues specialized in otherindustries, such as software and technology licensing,automation, and non-medical machine learning.

Representative experience
Multiple clients on the use of telehealth and otherdigital health applications to monitor COVID-19
patients in their homes.
Multiple clients – including high-technology companies– in drafting and negotiating agreements to develop

Contacts
Melissa K. Bianchi,
Washington, D.C.

Fabien Roy,
Brussels

Jodi Scott,DenverPractices
Privacy andCybersecurity
Communications,Internet, and Media
HealthDigital Assets andBlockchain

Industries
Life Sciences and HealthCare
Technology andTelecoms

and commercialize digital health products that dependon access to and exchange of data.
Multiple pharmaceutical companies on the use ofsoftware applications within a clinical trial setting.
A client on the development of a new digital healthproduct consisting of a mobile app for the patient andweb-based apps for HCPs.
A provider of advanced diagnostic imaging, outpatient,and cancer care on the generation of their digitalarchitecture strategy through licensing, joint venture,
and acquisition arrangements.
Two successful de novo applications to FDA for AI
medical products. IDx's product for use in diabetic
retinopathy screening and Viz.ai's product that analyzes
CT angiographic images to support acute stroke care.
A leading consumer product company on thedevelopment and classification of a consumer-oriented
wearable sensor and associated mobile application.
Various regulatory aspects of international
telemedicine, including cross-border health care, data
privacy, and medical device aspects.
Medical device manufacturers with structuring theirconnected medical device services to facilitate crossborder data transfers and streamline EU data protection
constraints.
Multiple life sciences companies on the use of data(including patient data) from handheld devices, mobileapps, tracking, and other personal devices for various
use scenarios.
Competition law aspects of blockchain technology,
which is explored for use in pharmaceutical supply
chain management and patient data handling.
Technology companies, as well as hospitals, healthplans, and biotech companies, on issues related to theuse of data in research contexts, health privacy and thecloud, and core HIPAA compliance.

Various regulatory aspects of international
telemedicine, including cross-border health care, data
privacy, and medical device aspects.
An international IT company concerning the use of AI insupport of medical practice, especially diagnosis ofdiseases, and the potential classification of related
software as a medical device in the EU.
Cisco Healthcare in rolling out its telemedicine products
in China and related regulatory issues.
A surgical robotic company on competition law aspects,
in particular as regards market definition in fields ofnascent technologies.

Latest thinking and eventsNews
New FDA clinical trials guidances promote efficient
drug development, innovative designs, diversity
News
IoT update: Implementing the EU Data ActNews
FDA promotes pre-approval for changes to devices,LDTs via PCCPs
NewsBreaking News for Breakthrough Devices: CMS
Finalizes Transitional Coverage for Emerging
Technologies Pathway
Insights and Analysis
Q2/2024 Life Science Law Update – Key developmentsfor pharma & device companies in EUNews
UK King’s Speech 2024: Key takeaways on dataprotection, AI, and cyber security