FDA Regulation of Mobile Health Devices

FDA Regulation of Mobile Health Devices

June 05, 2012 2:00 pm

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This recorded webinar discusses how software has increasingly become an integral part of healthcare, whether through incorporation into medical devices, as a stand-alone system that practitioners use to make clinical decisions, or as a means for transmitting and storing medical records.

The federal government has supported the growth of mobile health technology through various incentives and directives, but the regulatory landscape remains unsettled. This presentation will review the Food and Drug Administration’s approach to medical software regulation by providing a brief history, the FDA’s current regulatory position, and where we anticipate the FDA will head in light of recent Congressional prodding.

Guests Tatiana Melnik, Attorney of Information Technology, Healthcare IT and Intellectual Property with Dickinson Wright; and Brian Balow, Partner at Dickinson Wright, discuss the FDA regulation of mobile health devices. 

 

 

 

View the slides (PDF).


Tatiana Melnik, Attorney, Dickinson Wright PLLC

Tatiana Melnik

Tatiana Melnik is an attorney with the Dickinson Wright law firm where her practice focuses on information technology, healthcare information technology, intellectual property and privacy issues. Ms. Melnik sits on the Michigan Bar Information Technology Law Council, the Automation Alley Information Technology Committee, and is a Managing Editor of the Nanotechnology Law & Business Journal. Ms. Melnik holds a JD from the University of Michigan Law School, and a BS in Information Systems and BBA in International Business, both from the University of North Florida. Ms. Melnik regularly writes and speaks on issues surrounding healthcare information technology.

 


 

brian balowBrian Balow, Dickinson Wright

Brian Balow is a member of the law firm Dickinson Wright PLLC, where he concentrates his practice in the areas of information technology, intellectual property, and healthcare law. Brian served a five year tenure as the practice director for Dickinson Wright's Information Technology & Security, Intellectual Property, and Telecommunications Practice Department. Brian has worked with Fortune 100 clients over the last fifteen years on Information Technology-related matters (including telecommunications), including the drafting and negotiation of agreements, formulation and implementation of policies and procedures for the management of IT (including outsourcing-related issues), counseling and advising on privacy and data security issues, and assisting clients in favorably resolving disputes with IT vendors (including disputes with the BSA and SIIA).

More recently, Brian and his colleague Tatiana Melnik have spoken and written extensively on healthcare IT and telemedicine issues (including HIPAA/HITECH issues). In December of 2011, Brian contributed the chapter entitled “Allocation and Mitigation of Liability” to the ABA Health Law Section’s “E-Health, Privacy, and Security Law” treatise, and in February of this year, Brian and Tatiana co-presented on Social Media, Healthcare, and the Law at the national HIMSS conference. Brian and Tatiana also regularly counsel clients across the United States on heath IT and telemedicine-related matters.

Brian is a 1988 cum laude graduate of the University of Georgia School of Law, where he was twice a scholarship recipient and was Managing Editor of the Georgia Journal of International and Comparative Law. Following graduation, Brian served as a judicial law clerk to the Hon. James Harvey in the United States District Court, Eastern District of Michigan.



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