Trekkies and non-Trekkies alike will recognize the expression “resistance is futile” as a favored saying among the drones of the Borg collective of Star Trek fame. Obviously I’m paraphrasing with the title of this essay, but let’s ask ourselves a question: Is it a big deal that the Department of Health and Human Services still does not have an agreed-upon standard for electronic health record (EHR) interoperability? HHS has been yakking about this since 2005, when Mike Leavitt ran the department. Now we have Kathleen Sebelius and still no...

BOSTON – The last day of AdvaMed 2012 included a discussion of the case of Prometheus v. Mayo that left observers with little reason for optimism unless the observer was employed by a large commercial entity with a good budget for legal consultation. Otherwise, holders and would-be holders of intellectual property might find the outcome of Prometheus leaves them ill equipped to manage patents and patent portfolios in a way that steers around some of the issues that arose in the case, which is expected to not only reshape the contours of the patent landscape going forward, but could eviscerate a number of existing patents as well.

BOSTON — The second day of AdvaMed 2012, hosted by the Advanced Medical Technology Association (AdvaMed; Washington), included a session dealing with the recent guidance for responding to unsolicited inquiries into off-label indications, and many in attendance may have hoped for a promise from FDA that it would fill in the blanks in the December 2011 guidance on this subject.

BOSTON — Reform of healthcare delivery and payment are jointly the signature healthcare experiment in this first part of the 21st Century, and a paper in the August edition of Health Affairs demonstrates that at least one approach to bundled payment can suppress the rate of healthcare inflation without inflicting damage on quality of care. However, one member of a trade association said the latest research does little to allay fears that new technology will suffer under cost containment efforts.

BOSTON — The Advanced Medical Technology Association (AdvaMed; Washington) kicked off its annual meeting with a policy briefing, highlighting some of its imperatives for 2012, with issues of taxation dominating the agenda. Repeal of the device tax is obviously still high on the association's agenda, and Steve Ubl, president/CEO of AdvaMed, said the association's preference is that a repeal be packaged with legislation dealing with the oncoming fiscal cliff composed of other tax issues.

The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks at the number of lawsuits and withdrawn guidances, it’s difficult to avoid the urge to characterize the past three years in terms of clichés, such as “a bull in a china shop.” Perhaps the poster child for all this was the Menaflex 510(k), which we have discussed before. FDA’s rescission of this application was the most political move at FDA...