The Food and Drug Administration releases guidance allowing Institutional Review Boards to waive informed consent requirements for clinical studies that have minimal risk. This is a major win for researchers trying to use big data to look at populations as well as those working on precision medicine investigations. Informed consent has been in issue when you’re looking at large banks of biological specimens and the clinical data that goes with them, or just large volumes of clinical data that are needed to identify trends and other areas for potential research. The FDA reserves the right to modify its guidance as needed, but this is a good thing for many of us.
In other government news, CMS announces that it has changed the name of the Social Security Number Removal Initiative (SSNRI) to “New Medicare Card.” Seems like something that should have been an obvious solution from the beginning, but who wants to miss out on another non-pronounceable cluster of letters?
CMS also recently released the 2016 Open Payments data. A couple of my colleagues are apparently raking it in, but most of the folks I work with all had less than $100 in annual payments. Looking at the local landscape, Novo Nordisk and Pfizer were the cheapest lunch players, followed by GlaxoSmithKline. Salix Pharmaceuticals led the pack with an average lunch cost of $24. I’m sure their mealtime presentations on their diarrhea and constipation drugs was a real showstopper.
I know I’m a card-carrying member of the Grammar Police force, but I want to again stress the need for people to be proficient in writing. I’ve been doing a little CMIO augmentation work and was presented with some documentation from a recent consulting engagement. Not only were there font and spacing issues in the document (to the point of being distracting), but there were basic grammar issues that never should have seen the light of day. There is a difference between “it’s” and “its” and also between “there,” “their”, and “they’re.” If you’re only doing spell check and not a grammar check, you’re missing out. And if you embed Excel cells into a Word document, you’re going to miss out there as well.
These are small errors, but frankly they reduce the credibility of your work. I know I’m guilty of sometimes letting a blog get out the door with some errors, but I don’t have the luxury of peer review and am usually writing from a plane, train, or automobile if I’m not writing from a half-crashed state in a hotel room. If you are charging $300 per hour for your work, you had better read it carefully and consider having a friend look it over before you send it to a CMIO. I can’t take you seriously when your work looks like it was styled by a middle school student.
The CMIO whose shoes I am filling passed away unexpectedly and at a young age. It’s been a heartbreaking assignment, because she was clearly loved and respected. Despite the depressing circumstances, people have been extremely accommodating as I begin to get up to speed and work through my plans to sort through the projects that urgently need my attention.
A search process is in full swing, but I suspect they will have challenges trying to fill the position based on how it is funded. It’s cobbled together with 40 percent administrative funding, 40 percent IT funding, and 20 percent clinical funding. The ideal candidate needs to not only have experience and knowledge, but be willing to try to serve three different masters whose needs are sometimes at cross purposes. I’m just covering the administrative and IT functions and that’s been hard enough.
We have some interviews scheduled over the next several weeks, so I am interested to see if they find someone who is up to the challenge (and also wants to relocate to a mid-sized market and to a role that does not have an associated academic appointment). If you’re on my interview schedule, may the odds be ever in your favor.
At HIMSS17, I was invited to join a virtual book club with a great bunch of women from across the country. Every month we read something and then get together on a conference call to talk about the selection. It’s a diverse group of people, with several from the healthcare IT space, one from engineering, a couple of entrepreneurs, and a retired educator. One of them mentioned that she just started reading the most recent MACRA offering in the Federal Register. She said she was thinking of making it her book club selection and giving everyone a section to read and provide a cheat sheet and their interpretation. I’m pretty she just subconsciously wants to be ousted from her book club president role, but I know most of us who have had to read it wish we could have assigned it to someone else. This month we’re discussing the book I picked, so I hope it hit the mark and they don’t vote me off the virtual book club island.
I spend an insane amount of time on the road, so I keep my eye out for services or products that can make my life easier. I have to say I am seriously intrigued by DUFL, a service that stores your business wardrobe and then ships it to your destination. As you depart, you ship it back to them for laundering so it’s ready to go again. The DUFL app displays photos of your catalogued clothes so you can pack your virtual bag for shipping. They charge $99 per trip to pack, ship, retrieve, and launder your clothes and $9.95 per month for storage. Depending on whether you’re going to have to pay to check a bag and how many items you may have to have dry cleaned when your trip is finished, the return on investment calculation looks pretty good. That doesn’t even include the time needed to pack your clothes so they don’t end up a wrinkled mess. They also offer a sports service to ship your equipment with care. I’d be interested to hear from any readers who may have experience with DUFL, because I hate going to the cleaners, as the pile of clothes on my dining room chair can attest.
Email Dr. Jayne.