Back from a brief vacay to discover that leaves are littering the yard and porch as if it were autumn and then realizing that it is, in fact, autumn. The year is going by so quickly and there is so much to do. And with the brief and slight chill that is present in the air, my thoughts whiz right past Halloween to beginning to percolate ideas for the Thanksgiving week menus.
For those of you with your feed more secured to the ground, here is a bit of what happened this week:
- HHS Publishes the Sunshine Act Data – The very, very long-awaited publication of the data collected under the Sunshine Act designed to provide insight into the financial relationships between the medical products industry and key stakeholders such as physicians and teaching hospitals was published this week on the website of CMS. To say the least, the data base known as Open Payments is a big piece of machinery and navigating it is not so intuitive or easy as one might think (or hope). Nevertheless, it is there and ready to be explored.
- FDA Updates Ebola Page on Website – With the escalation of news regarding the Ebola outbreak in West Africa and the subsequent first case diagnosed in the United States, there is a consequential need for more in-depth information. This week FDA expanded upon its new Ebola section of the FDA Website that overviews a timeline of events, latest developments, FDA’s involvement, news about treatments – both investigative and fraudulent.
- More on Cyber Security and Medical Devices – Last week it was noted in the Weekly Roundup that FDA would be holding a public hearing on cyber security and medical devices. On the same topic, this week the agency announced availability of a guidance – “Content and PreMarket Submissions for Management of Cybersecurity in Medical Devices“. FDA is recommending that cybersecurity be a component of the design and development of a device and also are inviting manufacturers to submit their plans for patches to be provided to improve security for software.
That’s it for me this week. Have a good weekend everyone.
Photo Credit: Anne Becker