Challenges of Regulating Mobile Medical Apps: Legal and Regulatory Issues You Should Know About Click Here for Additional Resources
A conversation with Joseph Kim, MD, MPH (see bio), VP of Medical Affairs and Technology at Medical Communications Media, Inc., about the rapid development of mobile medical applications and the legal and regulatory issues that physicians, patients, and pharma developers/sponsors should be aware of.
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“So many different health apps pop up,” says Kim, a specialist in the use of technology in medicine. “How do you as a consumer, or as a physician, know which ones are reliable or which are accurate?”
“Unfortunately, the technology is moving faster than any regulatory body can keep up. Releasing an app is very easy,” he said, but if it is developed abroad, the standards may be different than they are in the United States.
“There are a lot of questions of liability that have yet to be answered. If a patient uses an app on the iPhone, who, at the end of day, is liable? If someone buys a WebMD Symptom Checker and there’s a problem, is the Apple store liable? Is WebMD liable?”
“The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play,” according to iMedicalApps. Dr. Jeffrey Shuren, Center for Devices and Radiological Health director, said that the FDA is planning to release guidance for mobile medical applications in sometime in 2011.
See Additional Resources.Questions/Topics Discussed
- What are pharmaceutical companies doing to reach physicians and other health care professionals via mobile devices?
- What are some of the potential concerns associated with mobile apps for health care professionals and/or patients/consumers?
- What are some of the privacy and security issues and concerns that surround mobile health apps?
- What role will the FDA play in regulating mobile health apps?
Dr. Joseph Kim is a physician executive, entrepreneur, and technologist who has a strong passion for health information technology, medical education, and public health. He frequently speaks at national conferences throughout the country about non-clinical careers for physicians, continuing medical education, mobile health technology, and social media utilization among physicians. He regularly contributes to the Physician Executive Journal, the official journal of the American College of Physician Executives.
Dr. Kim currently works in the field of continuing medical education as the Vice President of Medical Affairs and Technology at Medical Communications Media, Inc. He is also on the Board of Directors for the National Association of Medical Education Companies. Dr. Kim serves on the Emerging Technologies Committee for the Alliance for Continuing Medical Education.
As an entrepreneur, Dr. Kim founded NonClinicalJobs.com to provide resources and an online community for physicians interested in non-clinical careers called the Society of Physicians with Non-Clinical Careers. He also founded three medical websites that focus on health technology, smartphones, and mobile health: MedicineandTechnology.com, MedicalSmartphones.com, and MobileHealthComputing.com.
Dr. Kim holds a bachelor of science in engineering from the Massachusetts Institute of Technology, a doctorate of medicine from the University of Arkansas College of Medicine, and a master of public health from the University of Massachusetts Amherst School of Public Health.