It’s been quite an eventful year for mobile marketing.
Last fall, the Federal Communications Commission (FCC) began enforcing a strict new set of rules governing marketing calls and text messages directed at consumers on their mobile phones.
New provisions in the Telephone Consumer Protection Act (TCPA) introduced these tighter restrictions on mobile marketing and mobile messaging.
Posted in Healthcare, Regulation, Technology
The Telecommunications Industry Association recently stepped forward to put pressure on federal regulators to work on cultivating EHR certification guidelines for meaningful use that are more accommodating of mHealth.
The TIA wants the voluntary guidelines to be less than ridged so encourage the delivery of “healthcare in motion, virtually anywhere and at any time.”
Posted in mHealth, mHealth news, Regulation
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.
Posted in mHealth, Patient privacy, Regulation, Security
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.
Posted in Regulation
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.
Posted in Healthcare IT, Regulation
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.
Posted in mHealth news, Regulation
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.
Posted in Patient privacy, Regulation, Security