Technology, data and consumerism have shaken up nearly every sector of the healthcare industry, from patients to providers to health insurers to pharmaceutical companies. Digital Health innovators looking to harness emerging technologies face ever-increasing legal gray areas that require future-looking solutions.
At the forefront of the transforming Digital Health landscape, McDermott works with emerging and established organizations to make sense of it all and develop creative solutions to the transactional, regulatory and compliance obstacles that can slow adoption and growth.
This episode explores:
> Exciting new collaborations in the healthcare space
> Challenges companies face as they work through cross-industry ventures, from diligence to regulatory mapping
> Key considerations for data sharing and the use of de-identified data in digital health solutions
> Navigating cultural differences between traditional providers and new non-traditional parties
> Best practices for companies working to enter the healthcare space through collaborative ventures
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination and the move to value-based payment. These efforts brought changes to coverage of telehealth and other virtual care services, as well as information gathering for regulatory reform.
McDermott is pleased to bring you this review of key developments that shaped digital health in 2018, along with planning considerations and predictions for the digital health frontier in the year ahead.
The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation (GDPR) and in the United States at the state level. Notable new state legislation includes the California Consumer Privacy Act of 2018 (CCPA) and developments in a number of state data breach notification laws that may affect organizations that handle health information. At the same time, the US federal government sought ways to reduce the regulatory burden on healthcare industry participants and increase the flow of data to promote interoperability.
This report highlights the notable actions and guidance that will shape the data privacy and security landscape for healthcare providers, digital health companies and other healthcare industry stakeholders in the coming year.
New Laws Expand Telehealth in California
Can We Expect to See ONC’s Final Rule on Information Blocking Soon?
Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents
To Market, To Market: FDA’s Digital Health Precertification Program
Vetting Relationships for Telemedicine Collaborations
Telemedicine Collaborations and Partnerships: Key Considerations for Success
Reviewing Key Principles from FDA’s Artificial Intelligence White Paper
The Law of Digital Health offers an overview of the opportunities, challenges and strategies arising from the highly dynamic components of the digital health ecosystem: health information technology, big data and data analytics, telemedicine and mobile personal engagement tools.
This book helps business leaders and their advisors understand, embrace and manage the legal implications of existing laws and regulations, as well as emerging policies that affect digital health product development, go-to-market strategies and cross-industry collaborations.
Spearheaded by editors-in-chief and authors Bernadette M. Broccolo and Lisa Schmitz Mazur, and authored by more than a dozen McDermott Health lawyers, The Law of Digital Health provides first-of-its-kind legal information on the digital health space.
Published by the American Health Lawyers Association, The Law of Digital Health is now available to order.
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