Articles by Industry Expert

Why Partnerships are Key to the Science of Patient Input

By Nina L. Hunter PhD & Robert M. Califf MD – We recently announced the first FDA Patient Engagement Advisory Committee (PEAC), supported by the Center of Devices and Radiological Health (CDRH). The Committee will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients.


Misunderstanding Propublica

By Ashish Jha – In July the investigative journalists at ProPublica released an analysis of 17,000 surgeons and their complication rates. Known as the “Surgeon Scorecard,” it set off a firestorm. In the months following, the primary objections to the scorecard have become clearer and were best distilled in a terrific piece by Lisa Rosenbaum.


A Theory of Interoperability

By Keith Boone – Definitions of interoperability surround us, but all the attention in the world to definitions make very little difference in the end. I have a theory that people will believe two systems are interoperable when they can observe that the systems work together in simple ways with little to no effort, and in complex ways with some effort.


OCR Squeezed Between OIG and Funding Restraints

By Art Gross – The Department of Health and Human Services Office of Inspector General has issued a report that is critical of the Office for Civil Rights. OIG concluded that OCR is not fulfilling its responsibility to enforce HIPAA regulations that safeguard protected health information (PHI) and to ensure that organizations protect patient’s privacy.


Navigating the Sea of Innovation

By Nancy Pratt – We are currently at a crossroads in the healthcare industry. Executives are working overtime to try to figure out how to connect and integrate data to best support clinical practice and patient care management. With health systems concerned about balancing both needs, they now need to figure out how to leverage data to get the best value out of their investment.



Connecting Health and Care for the Nation

By Karen B. DeSalvo & Erica Galvez – This is a unique time in health care. Scientific and technological advancements made by you, our partners across the health industry, have been rapidly transforming health and health care in the nation. More than 3 million individuals have accessed their electronic health information using ONC’s Blue Button tool.


What to Expect When You’re Done Expecting ONC’s Final Rule

By Steven Posnack – I know you might be wondering, “what’s next?” now that ONC’s 2015 Edition final rule has formally published in the Federal Register. This milestone kicks off the next phase our work to implement the 2015 Edition’s regulatory requirements. Starting next week and over the next few weeks, ONC will be releasing two types of documents to immediately help jumpstart health IT development efforts to the 2015 Edition.