Practice Areas & Industries: Duane Morris LLP

 




mHealth, Telemedicine and Health Information Technology Return to Practice Areas & Industries

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Practice/Industry Group Overview

Duane Morris healthcare clients continue to witness the increasing influence and complexity of information technology in the delivery of healthcare. The delivery of health care wirelessly impacts reimbursement, privacy, practice of medicine and regulatory legal issues among others. The use of application software (apps) on a portable phone or tablet or web-based software accessed through a traditional medical device fall under the new area of "mobile health" (mHealth). Other terms that are used to describe this new phenomenon include "telemedicine" and "health information technology" (HIT). Virtually any entity or individual who participates in the healthcare system is affected—healthcare providers such as hospitals, physicians, and nursing homes; health plans and payors including Medicare and Medicaid; provider and plan vendors such as entities that perform patient data analysis, support the development of health information exchanges/organizations (HIEs or HIOs) or provide data storage. Entrepreneurs and investors are leading the way in the development of these products and services.

To address this emerging area, Duane Morris has developed a multidisciplinary client team whose members are experienced in addressing the legal issues that clients must consider in developing, funding or deploying a product or service that could be considered mHealth or telemedicine, or relies on HIT. These legal issues include:

  • government and private payor reimbursement;
  • privacy and security requirements, including breach responses, under the Health Insurance Portability and Accountability Act (HIPAA) and state laws;
  • Food and Drug Administration (FDA) reviews for devices;
  • intellectual property (IP) issues;
  • practice of medicine concerns;
  • corporate formation, operation and governance;
  • fraud and abuse issues;
  • Federal Communication Commission (FCC) oversight; and
  • other issues.

Our attorneys are keeping pace with the key issues that drive further convergence of healthcare and technology. The firm's mHealth Newsletter discusses recent advances and report on new developments in this rapidly evolving sector of the healthcare industry.


 
 
Articles Authored by Lawyers at this office:

FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
, December 11, 2013
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, the new...