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Healthcare Big Data and Meaningful Use Challenges with Mandi Bishop – Google Plus Hangout

Posted on September 23, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Note: The following image will become the live video stream about 5 minutes before the start of the G+ hangout and then will be the recorded video after the hangout. Subscribe Here to be notified of future hangouts and check out are list of scheduled Healthcare Scene hangouts.

What: A Google+ Video Hangout with Mandi Bishop, Principal at Adaptive Project Solutions, discussing the latest happenings with the use of big data in healthcare. Plus, we’ll also dig into some of the challenges healthcare organizations are facing when it comes to meaningful use.
Note: Mandi is also a blogger at EMR and HIPAA.
Date: Thursday, September 26, 2013
Time: 1:00 – 1:30 p.m. EST
Location: About 5 minutes before the event, we’ll embed the video stream on this page or you can find the video stream on the Healthcare Scene Google+ page as well.

Subscribe Here to be notified of future EHR and Healthcare IT hangouts and check out are list of scheduled Healthcare Scene hangouts.

The video will be available to view live on this page and the recorded video will be embedded on this page after the hangout as well.

If you have any questions you’d like to pose before or during the hangout, send them to @ehrandhit on Twitter.

Mandi Bishop, Principal at Adaptive Project Solutions
Mandi Bishop

FDA Issues Final Mobile Health App Guidance

Posted on I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Today the FDA announced the issuance of the final guidance on mobile health apps. You can find a PDF of the full mobile medical app guidelines here. The guidance won’t come as a surprise to those of us familiar with the industry. The guidance is basically what we expected the FDA to do with mobile health applications. The FDA plans to only offer regulatory oversight to those mobile medical apps which they define as a medical device. Here’s how they describe it in their press release:

The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.

Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.

“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

They further went on to explain that the FDA will focus its oversight on mobile health apps that:

  • are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Here’s the overarching premise of the FDA’s approach to mobile health app regulation, “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The last comment is what so many mobile health application developers have wanted. Hopefully this guidance will give them that assurance and clarity. Although, it’s a bit annoying when the final guidance document says “Contains Nonbinding Recommendations” at the top of every page. Legalese aside, I believe this document will provide the foundation for the FDA’s mobile health efforts going forward.

Are State Health Agencies Ready for Meaningful Use Stage 2?

Posted on I Written By

James Ritchie is a freelance writer with a focus on health care. His experience includes eight years as a staff writer with the Cincinnati Business Courier, part of the American City Business Journals network. Twitter @HCwriterJames.

As part of its public health objectives, Meaningful Use 2 requires doctors and hospitals to report sizable amounts of information.

The idea is that when significant patterns are forming — an outbreak of a certain disease, for example, or a peculiar cluster of symptoms — they’ll be apparent right away.

But someone has to be in position to receive the data.

The responsibility falls to local and public health departments. Agencies around the country should, theoretically, be preparing for the immunization records, laboratory results and other information they’ll soon be getting.

Just how many will be ready, though, remains to be seen. Many cash-strapped departments lack the IT infrastructure for what’s being asked of them — and the money allocated by the government hasn’t amounted to much, according to a 2012 American Journal of Public Health article by Drs. Leslie Lenert and David Sundwall.

In fact, the authors wrote, the federal effort “has created unfunded mandates that worsen financial strains” on health departments.

There’s a caveat, though: The mandates aren’t really mandates.

“Nothing compels them to do it” except the desire to do the right thing, said Frieda du Toit, owner of Lakeside, Calif.-based Advanced Business Software. “Some directors are interested, some are not. The lack of money is the main thing.”

In our recent interview, du Toit, whose company specializes in information management solutions for health departments, added: “One customer asked me: ‘Am I going to be punished in any way, form or fashion if I don’t support the efforts of my hospitals and care providers?”

Her firm’s Web-based Public Health Information Management System serves cities and counties throughout the United States, including in California, Texas and Connecticut.

The federal government’s goal is for public health agencies to be involved in four administrative tasks to support MU2, according to the Stage 2 Meaningful Use Public Health Reporting Task Force. The task force is a collaboration between the U.S. Centers for Disease Control and Prevention, nonprofit public health associations and public health practitioners.

The first step is to take place before the start of MU2 — that’s Oct. 1, 2013, for hospitals and Jan. 1, 2014, for individual providers.

The tasks:

  • Declaration of readiness. Public health agencies tell the Centers for Medicare & Medicaid Services what public health initiatives they can support.
  • Registration of intent. Hospitals and providers notify public health agencies in writing what objectives they seek to meet.
  • On-boarding. Medical providers work with health departments work to achieve ongoing Meaningful Use data submission.
  • Acknowledgement. Public health agencies inform providers that reportable data has been received.

For doctors and other eligible professionals, MU2 calls for ongoing submission of electronic data for immunizations. Hospitals are to submit not only immunizations but also reportable laboratory results and syndromic surveillance data.

Health care providers whose local public health departments lack the resources to support MU2 are exempt from the reporting requirements.

In Meaningful Use Stage 3, which health IT journalist Neil Versel wrote is likely to begin in 2017, “electronic health records systems with new capabilities, such as the ability to work with public health alerting systems and on-screen ‘buttons’ for submitting case reports to public health, are envisioned,” according to Lenert and Sundwall.

The authors noted: “Public health departments will be required not just to upgrade their systems once, but also to keep up with evolving changes in the clinical care system” prompted by the regulations.

They proposed cloud computing as a better way. Shared systems and remote hosting, Lenert and Sundwall suggested, could get the work done efficiently and affordably, albeit at a cost to individual jurisdictions’ autonomy.

As EMR adoption grows, it would be a shame not to take advantage of the opportunities for public health. The entire health IT effort being pushed by the federal government is, after all, geared toward improving the health of populations.

Without money for the job, though, public health agencies’ ability to support Meaningful Use will likely always be limited. It looks like a good time to think about committing significant funds, embracing cloud-based solutions or both.