Health Information Technology

On January 20, 2015, the FDA issued draft guidelines[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.
Continue Reading FDA Issues Guidance for Low-Risk General Wellness Products

In mid-December, President Obama signed into law a $1.1 trillion spending bill known as the “Consolidated and Further Continuing Appropriations Act, 2015” or “Cromnibus.”[1] This post explores provisions that relate to the health sector and Affordable Care Act (ACA) implementation.
Continue Reading Effects of the New Federal Spending Package on the Health Sector

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma) companies.  A recent report published by Research2Guidance,  indicates that most major pharmaceutical companies have had trouble generating downloads for their health-related apps and even when they do, have trouble getting users to continue using their products.[1]  For example, some of the most successful pharma companies have only a handful of apps and less than 1 million active users.[2]  By contrast, there are more than a hundred thousand health-related apps on Google’s Play store and Apple’s iTunes store based on recent calculations, and some experts estimate that there could be as many as 500 million users of medical applications by 2015.[3]  What is the cause of this inability to generate downloads or hang on to users?  There are a few possibilities.
Continue Reading Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design and development phases, and in preparation of pre-market submissions.[1] While the agency emphasizes that it has issued a guidance document containing only nonbinding recommendations, is there an underlying expectation that manufacturers address—and that agency staff assess— such planning as part of the approval process?
Continue Reading Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

September 9th was a significant day for Apple and its legions of loyal fans, but was it also the “beginning of a health revolution” as Apple alludes to?[1]  On September 9th, Apple announced its new iteration of the iPhone, the iPhone 6 running a new iOS 8 operating system, and also debuted its first wearable technology, the Apple Watch. The long awaited launch of these new devices also showcased software that Apple debuted earlier this year, Apple’s Health app and HealthKit platform which are integrated into the new operating system.
Continue Reading Is Apple Leading a Health Management Revolution?

The Statewide Health Information Network  of New York , also referred to as SHIN-NY, is a State-sponsored secure database network that is intended to house patient records, clinical data as well as other critical health care information across the State.  The network is designed to be an “information highway” which will enable New York clinicians and patients access to a comprehensive medical record and supplementary functions from virtually any location.[1] After several years of slow progress, the project is finally gaining momentum.
Continue Reading New York’s Health Information Highway – SHIN-NY – Get Involved as it Gets Rolling