Tag Archives: electronic health record

An Apple a day…


…will keep the doctors informed.

So maybe you haven’t been in the hospital ever or in years or even this year (we’re only a quarter-ish into the new year)… but now you just might see how an Apple might be just what the doctor ordered.

If you are already wearing that Apple Watch and happen to make it into the patient bed at Cedars-Sinai then you can synch all your info with the hospital issued iPad and your Apple Watch. That makes for a more complete record of your health and keeps the info where it can be accessed for other care providers or, in the worst of situations, where emergency responders can see it.

Back in early 2015, we heard of the hospitals piloting Apple’s HealthKit – and the big name electronic health record providers jumped in with them. John Hopkins (specifically for epilepsy)  and Ochsner Medical Center in New Orleans have worked with Epic, an electronic health record company, to integrate with the Apple Watch. Ochsner is making the use of the Apple product line to make their innovationOschner (iO) program a stellar role model for the rest of the electronic world of healthcare. I’m, personally, impressed with their program and how they seem to be making it a part of their strategic vision not just for the company but for their patients. Check out this post from last year on Oschner’s program

Yet, in the field we are all aware of the regulations around electronic health records and those devices that work with them are one of the grey areas – one that we, in the healthcare technology field hopes will stay grey!

What have your experiences been with your Apple products and your healthcare providers?

Here is a great interview article with a patient at Cedars Sinai –  and it speaks to the market that Apple is now wading into…


Cerner/Siemens merger is big news!!


Well, I was surprised on this one but I’m probably not the one “in the know” on deals such as this – but Cerner & Siemens $1.3 billion merger occurred last week. And I know that everyone from employees to users of the separate companies’ products to the whole HIT world are waiting to see what happens next. The article interviews John Glaser of Siemens and surprised me by noting that the merger has been a bit on the brains of the executives for quite some time – since 2010. Could this bring the two companies together and put them back in a powerhouse position? Guess we’ll have to wait and see. But honestly, with IT products, unless they have been working on programming since 2010, they don’t move that quickly.

Any thoughts from the audience?


FDA and mHealth: Upcoming FDASIA report implications


In watching what is going on with the FDA and mHealth, I’ve become a bit more nervous on the topics that are lying “in between the lines” of what the FDA is working with the ONC and FCC to determine where government fits in to the oversight and regulation of the apps. Most of the articles I read keep mentioning the apps that are medically oriented – which there are thousands – and then they slide in the software just once in a while. It’s the software that I am concerned with.

In an article from mobihealth news  March 3rd, Bradley Merrill Thompson talks about current events with the Food and Drug Administration Safety and Innovation Act (FDASIA) and the PROTECT Act. Congress gave specific direction to convene a working group which included the FDA (Food & Drug Administration) , ONC (Office of the National Coordinator for health information technology), and FCC (Federal Communications Commission) to make recommendations for the regulation or lack of regulation for HIT. The report from the group is due at the end of this month and frankly, based on my research, we don’t have a really good idea of what they are going to come out with. I talked about some of the questions that Congress recently sent to the FDA in a letter in this blog.

In the article from Mr. Thompson, he gives us a quick review of the Power Point that the FDA presented (Here and then click on the FDASIA Recommendations) and picks out some very good items that the FDA report needs to answer. He refers to slide 35 and notes that the FDA should be very concise about what software is regulated and what is not. This is one of those points that I cringe at. When you say software to me I am thinking electronic medical records but the overarching “software” really can refer to mobile apps or software that is privately produced by either individuals, organizations, or companies to assist with connecting the patient to medical/disease information, patient information collection or even interaction with clinical providers, among many others. It also specifically calls to software that is directly related to or interacts with a medical device. This is truly the first door that the FDA could reasonably step thru to have more oversight and regulation of medical software – specifically electronic medical records.

The second slide he refers to, 36, speaks to defining requirements. These requirements are from development to deployment and then the post deployment updates for the apps. We, in the industry of healthcare IT, need to know the requirements before we start building these apps. Otherwise, the development is severely impacted financially. You can imagine that you spend, for example, 100 hours creating the app and for each of the hours you paid the developer $60. Then you find out after you’ve finished the app and are ready to deploy it to the public that you don’t meet the FDA requirements. That is a lot of money for any business to absorb. Additionally, if you have already deployed the app and are doing updates then you have the same concerns. And next Mr. Thompson notes that slide 37 truly drives home the fact that these regulations need to be entrepreneur friendly. Again, the regulations and requirements for the software need to be known or communicated as well as reasonable.

Generally, the FDA, ONC and FCC should be looking at which software or apps directly touch the patient and medical devices, create clear, concise and communicated regulations so that the entrepreneurs, established companies and organizations can adhere to the regulations at the very beginning. They should also consider for those apps or software already established what the reasonable regulations and timeline for any changes required should be. The industry is very far along and has complex software that could be adversely affected and the economic impact could be significant.

 

Any thoughts on the upcoming report and it’s potential impact on mHealth?

 


The road to integration & public health with children


Found a reminder of how long we have been working on integration – specifically for children’s health. Question- what happened to this movement that we forgot about the public health aspect? Or is there another hiding out there?

The All Kids Count II program, funded by the Robert Wood Johnson Foundation (RWJF) from 1998–2000, sought to make 16 immunization registry projects based in local, county, and state health departments fully operational by January 1, 2000. The program also sought to develop a long-term policy to ensure registries are implemented and sustained nationwide. The program built on progress made under All Kids Count Phase I, 1992–1997, an RWJF program to begin the development of registries.

The national program office was based at the Task Force for Child Survival and Development in Atlanta, with guidance from the program’s National Advisory Committee, the national program office gave grants ranging from $300,000 to $700,000 to 16 projects

Here is an overview and the results from the program:

http://www.rwjf.org/reports/npreports/akc.htm


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