Digital health—USA—Q&A guide

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

Digital health—USA—Q&A guide
1. Who are the key players active in your local digital health market and what are the most prominent areas of innovation?
2. How would you describe the investment climate for digital health technologies in your jurisdiction, including any noteworthy challenges?
3. What are the most notable recent deals in the digital health sector in your jurisdiction?
4. What due diligence issues should investors address before acquiring a stake in digital health ventures?
5. What financing structures are commonly used by digital health ventures in your jurisdiction? Are there any notable government financing or other support initiatives to promote development of the digital health space?
6. What principal legislation governs the digital health sector in your jurisdiction?
7. Which notable regulatory and enforcement bodies have jurisdiction over the digital health sector?
8. What licensing and authorisation requirements and procedures apply to the provision of digital health products and services in your jurisdiction?
9. Is there any notable ‘soft’ law or guidance governing digital health?

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10. What are the key liability regimes applicable to digital health products and services in your jurisdiction? How do these apply to the cross-border provision of digital health products and services?
11. What constitutes ‘health data’? Is there a definition of ‘anonymised’ health data?
12. What legal protection is afforded to health data in your jurisdiction? Is the level of protection greater than that afforded to other personal data?
13. Is anonymised health data subject to specific regulations or guidelines?
14. How are the data protection laws in your jurisdiction enforced in relation to health data? Have there been any notable regulatory or private enforcement actions in relation to digital healthcare technologies?
15. What cybersecurity laws and best practices are relevant for digital health offerings?
16. What best practices and practical tips would you recommend to effectively manage the ownership, use and sharing of users’ raw and anonymised data, as well as the output of digital health solutions?
17. What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?
18. What is the patent application and registration procedure for digital health technologies in your jurisdiction?
19. Are any other IP rights relevant in the context of digital health offerings? How are these rights secured?
20. What practical considerations are relevant when licensing IP rights in digital health technologies?
21. What procedures govern the enforcement of IP rights in digital health technologies? Have there been any notable enforcement actions involving digital health technologies in your jurisdiction?
22. What rules and restrictions govern the advertising and marketing of digital health products and services in your jurisdiction?
23. What rules governing e-commerce are relevant for digital health offerings in your jurisdictions?
24. Are digital health products and services covered or reimbursed by the national healthcare system and private insurers?
25. What have been the most significant recent developments affecting the digital health sector in your jurisdiction, including any notable regulatory actions or legislative changes?
26. What emergency legislation, relief programmes and other initiatives specific to your practice area has your state implemented to address the pandemic? Have any existing government programs, laws or regulations been amended to address these concerns? What best practices are advisable for clients?

Digital health—USA—Q&A guide

This Practice Note contains a jurisdiction-specific Q&A guide to digital health in USA published as part of the Lexology Getting the Deal Through series by Law Business Research (published: February 2021).

Authors: Seyfarth Shaw LLP—Chris DeMeo; Sheryl Tatar Dacso; Tonya M. Esposito; Brian L. Michaelis ; John P. Tomaszewski

1. Who are the key players active in your local digital health market and what are the most prominent areas of innovation?

The US digital health market is one of the largest consumers of healthcare dollars in the world. The market is made up of companies involved in the development and deployment of technology, applications, health and individual services and user connectivity. These categories have experienced dramatic growth, most recently because of covid-19. The growth is in mobile health (mHealth), telemedicine, healthcare analytics and digital health devices. Companies recognised by Market Research Future as key players include iHealth Lab, General Electric, Cerner Corporation, BioTelemetry, McKesson, Cisco, Athenahealth, AT&T, EClinicalWorks, Allscripts and Qualcomm. In addition, research institutions such as TMC|X in Houston, Texas, through its business accelerator programme, and the University of California Los Angeles, through its Depression Grand Challenge, are partnering with industry to develop innovative treatment models. Transformational digital health strategies include innovations in telemedicine, AI and electronic health records geared to streamline access, improve quality, reduce error and lower costs. Increasing consumerism in healthcare

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