Some think digital health is snake oil, i.e. a product that is deceptively advertised or promoted to do something that it has not been proven to do. After all, mobile medical apps don't come with package inserts and that cotton stuffed in the bottle.
Like most things, the answer is not straight forward. Consider:
From text messages to mobile apps, digital health devices are becoming increasingly important in clinical trials for their ability to streamline trials, lower site burden, and improve the patient experience. However, manufacturers must consider the safety, reliability, and convenience of these devices in order to effectively implement them into medical device trials. The digital components of these medical device trials must adhere to the same rigorous regulatory standards as the device itself, which can pose significant hurdles for some sponsors. Those hurdles include:
A recent review concluded that "Safety of apps is an emerging public health issue. The available evidence shows that apps pose clinical risks to consumers. Involvement of consumers, regulators, and healthcare professionals in development and testing can improve quality. Additionally, mandatory reporting of safety concerns is needed to improve outcomes."
So, is digital health snake oil? It depends. Some are. Some are not. But we have much to do before we can stop asking the question.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs on Twitter@ArlenMD and Co-editor of Digital Health Entrepreneurship
Arlen Meyers, MD, MBA is a professor emeritus of otolaryngology, dentistry, and engineering at the University of Colorado School of Medicine and the Colorado School of Public Health and President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org. He has created several medical device and digital health companies. His primary research centers around biomedical and health innovation and entrepreneurship and life science technology commercialization. He consults for and speaks to companies, governments, colleges and universities around the world who need his expertise and contacts in the areas of bio entrepreneurship, bioscience, healthcare, healthcare IT, medical tourism -- nationally and internationally, new product development, product design, and financing new ventures. He is a former Harvard-Macy fellow and In 2010, he completed a Fulbright at Kings Business, the commercialization office of technology transfer at Kings College in London. He recently published "Building the Case for Biotechnology." "Optical Detection of Cancer", and " The Life Science Innovation Roadmap". He is also an associate editor of the Journal of Commercial Biotechnology and Technology Transfer and Entrepreneurship and Editor-in-Chief of Medscape. In addition, He is a faculty member at the University of Colorado Denver Graduate School where he teaches Biomedical Entrepreneurship and is an iCorps participant, trainer and industry mentor. He is the Chief Medical Officer at www.bridgehealth.com and www.cliexa.com and Chairman of the Board at GlobalMindED at www.globalminded.org, a non-profit at risk student success network. He is honored to be named by Modern Healthcare as one of the 50 Most Influential Physician Executives of 2011 and nominated in 2012 and Best Doctors 2013.