- State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding
- Increased Spotlight on Emergency Department Facility Coding by CMS, HHS and DOJ
- Duane Morris Partner David Charapp Awarded 2013 Client Choice Award
- FCC Releases Decision on New Funding Program for Rural Health: Broadband Connectivity Prioritized and the Expansion of Telemedicine and mHealth Continues
- M-Health: The Union of Technology and Healthcare Regulations
- Duane Morris Special Counsel Michael Swit to Present at Drug Information Association 49th Annual Meeting"
- Duane Morris Attorneys Lisa Clark, Ken Keane and Michael Swit to Explore "mHealth Converges—The Impact of FCC, HIPAA/Privacy and FDA Challenges"
- Mobile Medical Applications
- FDA Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications
- FDA Proposes Health 'App' Guidelines
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, spearheaded by health law partner Lisa W. Clark, 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.
mHealth Newsletter—November 14, 2012 [PDF Version]
- The P's & Q's of mHealth and Patient Engagement; Privacy and Security Issues
- Healthcare Reform and New mHealth Business Opportunities: What mHealth Entrepreneurs Should Know After the Presidential Election
- mHealth and the FCC: What Does the FCC Have to Do with Medical Devices?
- mHealth and Home Health: A Natural Fit
- AliveCor Veterinary ECG Model Paves FDA-Friendly Path to the Market
mHealth Newsletter—May 21, 2012
About Duane Morris
Duane Morris LLP is a full-service law firm of more than 700 lawyers, dozens of whom advise a wide range of healthcare organizations, including hospitals, assisted living residences and other providers, on all aspects of regulatory compliance and enforcement, corporate, reimbursement, litigation, labor and employment, real estate and taxation matters.