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Whenever fact sheets or other guidance is issued by either the Office of the National Coordinator for Health Information Technology (ONC) or the Office for Civil Rights (OCR), it helps gain insight into the thinking of the regulators so we watch it closely.

But when the ONC and OCR issues joint guidance, it is hitting the jackpot.
Continue Reading ONC and OCR Issue Joint Fact Sheet on Use of PHI for Public Health Activities

The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days.

The guidance is intended to assist all parties associated with clinical research with the appropriate use of electronic health records in FDA-regulated clinical investigations, which in…

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR), and the Food and Drug Administration (FDA) announced that they had…

Last Friday (January 22, 2016), the Food and Drug Administration (FDA) published draft guidance for medical device makers on the importance of including cybersecurity measures in approved products. Further, the guidance highlights the importance of  reporting any post-approval fixes to assist others with cybersecurity measures, particularly for medical devices connected to the Internet.

The guidance,…

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant portion of these devices will be medical devices such as pacemakers, in-home monitoring systems and…

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital computer networks, commandeer the pumps and manipulate the dosage given to patients. There has been no reporting hacking incident, but…