Archive | Regulation

TrueVault Making Strides for mHealth

TrueVault Making Strides for mHealth   TrueVault patient privacy mHealth news mHealth In the last round of bills to pass through Congress, we saw a slate of healthcare reform acts, as well as a stimulus package, which was designed to help jumpstart President Obama’s efforts to encourage for more affordable healthcare.

One of the provisions introduced in an aforementioned bill calls for new HIPAA regulations and advanced security protocols for patient information. These regulations significantly impact the ways that technology companies have been developing apps and software for hospitals and doctors’ offices.

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FDA To Require Electronic Reporting of Medical Device Errors

FDA To Require Electronic Reporting of Medical Device Errors   mobile medical devices mHealth MDRs FDA regulations FDA Last week, The U.S. Food and Drug Administration published a final rule in the Federal Register which requires that both device makers and importers document negative event reports for medical devices electronically.

“Upon the effective date of this final rule, manufacturers and importers are required to submit MDRs to the Agency in an electronic format that FDA can process, review, and archive,” the FDA announced.

The new rule formally takes effect August 14th, 2015.
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iPatientCare is ‘Ready’ for ICD-10

iPatientCare is Ready for ICD 10   mHealth iPatientCare ICD 10 While October 1, 2014 may sound like it is a long time away, healthcare providers have the daunting task of transitioning from ICD-9 to ICD-10. The transition is a long and involved process, which will require a significant amount of planning, preparation, and employee hours to ensure that a practice is ready by the deadline.

Last week, the team at iPatientCare, a pioneer in mHealth and cloud-based ambulatory EHR solutions, announced its “readiness” for the transition to ICD-10.

All HIPAA-covered healthcare entities are required to switch to the new code set by October 1, meaning that their EHR software and medical billing systems must be compliant. Any claims submitted with ICD-9 codes for services provided on or after the October compliance deadline will not be paid.
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FDA Lifts Restrictions on Social Media Ads

FDA Lifts Restrictions on Social Media Ads   social networking social media news social media marketing social media mobile ads internet FDA Advertising It’s safe to expect an increase in pharmaceutical ads on social networking sites resulting from a new FDA draft guidance document.  Many in the industry feel the announcement is a good start.

As far as the FDA’s reporting requirements for ads, the guidance is not as far reaching as some have hoped.  That could change in July when it is required that the FDA issues guidance that elaborates on the policy.

Wayne Pines, president of regulatory services and healthcare at APCO Worldwide, praised the draft.

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The First Practice Found In Breech of The HITECH Act

The First Practice Found In Breech of The HITECH Act   security HITECH act healthcare Breech of The HITECH Act In 2009, the HITECH Act was put into place to protect the privacy and security of patient information that is stored on portable electronic tools and devices. Last week in Concord, Massachusetts, Adult & Pediatric Dermatology, P.C. was the first to pay a settlement for a HITECH Act violations. They agreed to the amount of $150,000 that will be paid to the U.S. Department of Health & Human Services Office for Civil Rights.

The settlement is in response to a thumb drive that contained protected health information for 2,000 patients. The thumb drive was stolen out of one of the Dermatology employee’s cars.

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The U.S. Department of Health & Human Services Proposes A New HIPAA Rule

The U.S. Department of Health & Human Services Proposes A New HIPAA Rule   U.S. Department of Health and Human Services HIPAA rules HIPAA health compliance In an effort to ensure compliance, the U.S. Department of Health and Human Services recently issued a proposed rule that would require each CHP to submit a “snapshot” of information to document their compliance to the HHS secretary. This would be part of the HIPAA auditing program that goes into effect this year. The documentation would showcase the CHPs compliance with all new standards and operating rules for the 3 electronic transactions that are being put into place under the Health Insurance Portability and Accountability Act.

The 3 electronic transactions that will be under watch for compliance are eligibility for health plans, healthcare claim status, and healthcare electronic funds transfers (EFT) and remittance advice (ERA) transactions.

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What Will 2014 Bring for Mobile Healthcare?

What Will 2014 Bring for Mobile Healthcare?   regulations mobile health news mHealth healthcare FDA Though medicine is not the first industry that we think of when it comes to companies who can utilize mobile technology, this year will see a huge mobile transformation for the world of medicine.

While most other industries have already been heavily influenced by the mobile revolution, healthcare has largely avoided this transition to same aggressive degree. Most experts believe, however, that the healthcare arena is growing tired of missing out when it comes to embracing new technologies, and are pleased to see that some segments within the industry are open to change this year.

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