Lisa Mazur
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Lisa Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape. Read Lisa Mazur's full bio.
What You Need to Know about Changes to the Common Rule
By Lisa Mazur, Bernadette M. Broccolo, Chelsea M. Rutherford, Jennifer S. Geetter and Jiayan Chen on Feb 10, 2017
Posted In Data Privacy, General Interest, Uncategorized
The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data repositories and use of those repositories for secondary research. All stakeholders involved in federally funded research should be aware of the...
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Digital Health Solutions are Key to Success under Health Care Payment Innovations
By McDermott Will & Emery, Bernadette M. Broccolo and Lisa Mazur on Dec 20, 2016
Posted In General Interest, Mobile Apps, Telehealth
Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is...
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Digital Health’s Perfect Storm of Regulators
By McDermott Will & Emery, Bernadette M. Broccolo and Lisa Mazur on Dec 19, 2016
Posted In General Interest, Telehealth
Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been...
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End of Year Attention to Health IT and Digital Health Tools in 21st Century Cures
By Daniel F. Gottlieb, Jennifer S. Geetter, Karen S. Sealander, Lisa Mazur and Scott Weinstein on Dec 13, 2016
Posted In Consumer Protection, Data Privacy, Telehealth
On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive...
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Congress Continues to Focus on Integrating Telehealth Solutions into Healthcare Delivery
By McDermott Will & Emery, Lisa Mazur and Marshall E. Jackson, Jr. on Dec 7, 2016
Posted In Telehealth
On December 6, 2016, the House passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the Senate on November 29, 2016. The ECHO Act seeks to expand the use of health care technology and programming to connect underserved communities and populations with critical health care services....
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Bipartisan Legislation Proposes Telehealth Solutions for Effective Chronic Disease Management
By Dale C. Van Demark, Lisa Mazur and Marshall E. Jackson, Jr. on Nov 28, 2016
Posted In General Interest, Telehealth
Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December of 2015, have driven the Senate Finance Committee to introduce a draft of bipartisan legislation known as the CHRONIC Care Act, which seeks to...
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Commercial Insurers Urge Congressional Budget Office to Consider their Telemedicine Data
By Lisa Mazur on Oct 28, 2016
Posted In General Interest, Telehealth
In hopes of expanding reimbursement opportunities for telemedicine services in the Medicare program, representatives of eleven payers, including Aetna, Anthem, Blue Cross Blue Shield of Tennessee, Cambia Health Solutions and Humana, asked CBO director Keith Hall in a public letter to consider their data when evaluating the impact of Medicare coverage of telemedicine services. Medicare...
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FTC Weighs-in on Telehealth, Comments on Delaware’s Occupational Therapy Practice Rule
By McDermott Will & Emery, Ashley Fischer, Lisa Mazur and Marshall E. Jackson, Jr. on Sep 15, 2016
Posted In General Interest, Mobile Apps, Telehealth
On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation). The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its...
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Digital Health: An Improving Environment for Investors
By Dale C. Van Demark and Lisa Mazur on Jul 12, 2016
Posted In General Interest, Mobile Apps, Telehealth
The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health...
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AMA Approves New Ethical Guidance Policy and Encourages Telemedicine Training for Students and Residents
By McDermott Will & Emery and Lisa Mazur on Jun 20, 2016
Posted In Consumer Protection, Data Privacy, General Interest, Mobile Apps, Telehealth
New Ethical Guidelines On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance. Consistent...
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