Category Archives: Health Information Technology

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Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online pharmacies – such risks including the dispensing of drugs (including addictive drugs to be used recreationally) without a valid prescription, … Continue Reading

A Stick to Balance the Carrot: ONC Finalizes a New Framework to Address Non-Conformities in Certified Health Information Technology

The Office of the National Coordinator for Health Information Technology (ONC) has released a final rule (Final Rule) introducing a new regulatory framework for certified health information technology (Health IT). The use of certified Health IT—specifically, electronic health record (EHR) modules—has played a central role in the EHR Incentive Programs and is intimately linked to … Continue Reading

Mississippi Advances with Telehealth, Shows Promise for Improved Diabetes Disease Management

Rightly or wrongly, Mississippi is not generally regarded as a leader in health. The state, which opted out of the Affordable Care Act (ACA) Medicaid expansion, consistently ranks in the bottom two states for most health indicators: infant mortality and low birth weight, obesity, cancer deaths, and diabetes outcomes.  Mississippi, however, is making significant efforts … Continue Reading

Healthcare Systems Offer Shared Medical Visits to Address Physician Shortages and Chronic Illnesses

With the advent of an increasing aging population, physicians and other healthcare providers are seeking alternative approaches in offering patients access to quality health care.  Among the innovations in healthcare delivery is the practice of shared medical appointments, where one or more healthcare providers (e.g. physicians and nurses) will see a group of eight to … Continue Reading

Go For De Novo: FDA’s Revised Approach to Medical Device Accessories

Accessories are an everyday reality for almost all users of technology products today.  They can help improve efficacy, increase usability and make many other improvements to the technology we use.  Increasingly, accessories are used for health related applications (e.g., smartwatches that connect to glucose meters).  In the healthcare space, accessories can potentially face regulation by … Continue Reading

Interface without Regulation – FDA Deregulates MDDS and Related Technologies

2015 has been a busy year for the Food and Drug Administration (FDA).  In January, the FDA issued guidance documents addressing wellness applications[1] as well as accessories to medical devices and it looks like the administration is continuing the trend into February with a finalized regulatory approach to Medical Device Data Systems (MDDS)[2].  All three … Continue Reading

FDA Issues Guidance for Low-Risk General Wellness Products

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 … Continue Reading

Effects of the New Federal Spending Package on the Health Sector

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

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

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 … Continue Reading

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

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 … Continue Reading

New York’s Health Information Highway – SHIN-NY – Get Involved as it Gets Rolling

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 … Continue Reading
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