AliveCor

With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”

While this sounds nice, how, exactly, does one become a “prescribed patient?”  Once a doctor “prescribes” such a device, what are his responsibilities?  Does this obligate the physician to 24/7/365 availability for EKG interpretations?  How are HIPAA-compliant tracings sent between doctor and patient?  How are the tracings and medical care documented in the (electronic) medical record?  What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?

At this point, no one knows.  We are entering into new, uncharted medicolegal territory.

But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device.  But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.

This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them.  So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:

Continue reading “When Patients Can Obtain Their Own EKG”

Share on Twitter

FROM THE VAULT

The Power of Small Why Doctors Shouldn't Be Healers Big Data in Healthcare. Good or Evil? Depends on the Dollars. California's Proposition 46 Narrow Networking

Masthead

Matthew Holt
Founder & Publisher

John Irvine
Executive Editor

Jonathan Halvorson
Editor

Alex Epstein
Director of Digital Media

Munia Mitra, MD
Chief Medical Officer

Vikram Khanna
Editor-At-Large, Wellness

Joe Flower
Contributing Editor

Michael Millenson
Contributing Editor

We're looking for bloggers. Send us your posts.

If you've had a recent experience with the U.S. health care system, either for good or bad, that you want the world to know about, tell us.

Have a good health care story you think we should know about? Send story ideas and tips to editor@thehealthcareblog.com.

ADVERTISE

Want to reach an insider audience of healthcare insiders and industry observers? THCB reaches 500,000 movers and shakers. Find out about advertising options here.

Questions on reprints, permissions and syndication to ad_sales@thehealthcareblog.com.

THCB CLASSIFIEDS

Reach a super targeted healthcare audience with your text ad. Target physicians, health plan execs, health IT and other groups with your message.
ad_sales@thehealthcareblog.com

ADVERTISEMENT

Log in - Powered by WordPress.