EHR and Health IT Consulting
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EHR and Health IT Consulting
Technical Doctor's insights and information collated from various sources on EHR selection, EHR implementation, EMR relevance for providers and decision makers
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Software: the new drug | Healthcare IT News

Software: the new drug | Healthcare IT News | EHR and Health IT Consulting |

Imagine software as medicine – a type of drug meant to heal diabetes, for example, or prevent strokes or heart failure.

That's the premise that Anand Iyer, president and CEO of WellDoc, put forth Tuesday at the mHealth Summit as he spoke about his company's plans. Iyer has long fancied a day when software would be prescribed just like any other medicine.

That day has come, he says. Welldoc's Bluestar, which Iyer describes as "mobile prescription therapy," or MPT, has been cleared by the FDA, and it's reimbursable by health plans, just like prescribed pharmaceuticals would be. Iyer raised $20 million from Merck Global Health Innovation Fund and Windham Venture Partners at the beginning of 2014 to help his idea gain traction.

Iyer, who himself was diagnosed with diabetes in 2002, was one of a four-member panel at an mHealth conference titled, "M2M Now Money Talks." He said he has high hopes for a future in which his interactive diabetes management tool – and others' platforms, too – have achieved drug-like status.

Bluestar's business model is based on the pharma model, said Iyer: "the disruptiveness of the model is that it's not disruptive at all."

Others on the mHealth Summit panel are working on similar technology-as-medicine offerings.

David E. Albert, MD, a physician and former GE scientist turned serial entrepreneur, would be the first to say developing new technology is hard work. But proving that it works is even harder, he said: You have to prove it works, and you have to prove it will do no harm.

Albert has founded three tech companies. The most recent is AliveCor, where he serves as chief medical officer.

He created the AliveCor Heart Monitor and the AliveECG app, which he describes on the AliveCor website as a "personalized, easy-to-use device that records accurate ECGs and heart rate anywhere, anytime at an affordable cost."

The product is certified as a Class II medical device by the Food and Drug Administration.

To bring this type of technology to market, requires serious research and substantial investment, he said – as well as proof, which requires many successful trials, he added, as he zipped through the results of trials published by the Cleveland Clinic, USC, University of Oklahoma, and more.

"Each of these trials has been done in the last two years," he said. "That's what you have to do.

"If you want to be in the mobile medical business, if you want Cleveland Clinic and Mass General to use your technologies, you have to prove it," he added. "You have to earn that credibility."

The technology is described on the AliveCor website: "The AliveCor Heart Monitor, when used with the free AliveECG app, is a personalized, easy-to-use device that records accurate ECGs and heart rate anywhere, anytime at an affordable cost. Simply rest it on your fingers or chest to record an ECG in just 30 seconds. And know right away if atrial fibrillation is detected."

The monitor's medical grade ECG recordings can also be shared directly with a physician, or sent to a cardiologist or cardiac technician through a cloud-based ECG analysis service provided by AliveCor, Albert said. In as little as 30 minutes users can receive expert reviews of their ECGs directly through the AliveECG app providing a more complete picture of their current heart health.

"We're saving lives every day," said Albert. "We got there through clinical research."

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Meaningful Use Problems Go Beyond Just Software, Say “Stage 2 Flexibility” Critics

Meaningful Use Problems Go Beyond Just Software, Say “Stage 2 Flexibility” Critics | EHR and Health IT Consulting |

The final rule for meaningful use Stage 2 flexibility, released late on Friday by the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC), is not as popular as the government probably would have liked.

The rule does allow eligible professionals (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs) to use 2011 Edition certified electronic health record (EHR) technology (CEHRT)  or a combination of 2011 and 2014 Edition CEHRT for an EHR reporting period in 2014 for the Medicare and Medicaid EHR Incentive Programs. However, the government has received sharp criticism from industry associations that the flexibility offered in these modifications was not enough to save hospitals and providers from receiving penalties down the line.

Robert Tennant, senior policy advisor of the Medical Group Management Association (MGMA), says while his organization is grateful for the focus on the CEHRT software, most of MGMA’s recommendations, as well as the other comments CMS and ONC received, and many of the overall problems with meaningful use were ignored.

“They’ve decided to focus exclusively on the issue of the software not being ready. We believe the problems with Stage 2 go beyond the CEHRT. That’s certainly an issue and we’re pleased they’ve given EPs flexibility for 2014 but that doesn’t solve the many other issues with Stage 2, not least of all, some of the new requirements have proven to be extremely onerous and forced EPs to rely on the actions of third parties,” says Tennant, speaking exclusively to Healthcare Informatics.

“The software issues are a problem, this definitely helps. But they made it adamant in the final rule that any criticism to the measures themselves were out of scope. They dismissed all of the industry recommendations.”

Tennant is frustrated that CMS and ONC continue with an “all or nothing” approach. He says the fact that an EP or EH can be 99.9 percent of the way there and fail sends the wrong message to the industry. Specifically, he mentioned the challenging transitions of care measures, which recent research showed that only a small number of EPs and EHs were able to meet.

The MGMA’s policy head mentioned the reporting requirements, and the lack of flexibility offered by CMS and ONC, as another reason the modifications weren’t enough for providers and hospitals. CMS and ONC are still requiring hospitals to engage in a 365-day reporting period in second-year Stage 2 reporting in 2015, rather than an industry-proposed 90-day reporting period. This means they have less than one month to get certified electronic health record (EHR) software in place in time to begin the mandatory reporting, since the fiscal year begins on Oct. 1, 2014.  

Speaking on this matter to HCI, Russell P. Branzell, president and CEO of the Ann Arbor, Mich.-based College of Healthcare Information Management Executives (CHIME), was none too pleased with ONC and CMS’ efforts. “For a program that we still believe is absolutely essential and absolutely important to gain momentum, we are absolutely shocked that no flexibility was given in this case, with regard to 2015. Their rationale was that they wanted to create more momentum. But this does the opposite,” Branzell said.

This sentiment was echoed by Chantal Worzala, director of policy at the American Hospital Association. In a statement, she said: "The American Hospital Association appreciates the flexibility offered by CMS. Unfortunately, this rule offers little relief because CMS did not grant a shorter reporting period for FY 2015, which begins on Oct. 1."

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