Telehealth Buzz

IOM Urges FDA to Replace Medical Device Clearance Process

The Institute of Medicine (IOM) has urged the U.S. Food and Drug Administration (FDA) to develop a new regulatory framework to replace the Agency’s 35-year old clearance process for medical devices.  The IOM concluded that the FDA’s “510 (k)” regulatory process may not provide for a reliable premarket screen of the safety and effectiveness of […]

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GPTRAC Hosts Annual Patient Awareness Initiative at Minnesota State Fair

The Great Plains Telehealth Resource and Assistance Center (GPTRAC) will host its Annual Patient Awareness Initiative at Minnesota’s State Fair, August 25th – September 5th 2011. The initiative serves to educate fairgoers about the capabilities of telemedicine services, while improving skin cancer awareness by stressing the importance of regular communications with healthcare providers about this […]

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TRCs Co-host Next CTeL Brown Bag Webinar Monday, August 15th

“Are You a Medical Device Manufacturer? The FDA’s Final Rule on Medical Devices” Tune in Monday, August 15, 2011 at 12:00 Noon (EDT), for the FREE CTeL Brown Bag Webinar, “Are You a Medical Device Manufacturer: The FDA’s Final Rule on Medical Devices.”  Anthony Pavel, JD, expert FDA attorney from the law firm of K&L Gates […]

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CTeL’s 50 State Survey on Medicaid Telehealth and Telehomecare Policies Now Available

CTeL surveyed all 50 state Medicaid offices to find out whether their state reimburses for telehealth and telehomecare services.  The results of this 50 state-survey can be found in CTeL’s Research Library.  Furthermore, CTeL has provided the state manuals and other documentation from the states that do reimburse for telemedicine services. Click here to download […]

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Next CTeL and NRTRC Brown Bag — Are You a Medical Device Manufacturer: FDA’s Final Rule on Medical Devices

If you are a medical device manufacturer or a telehealth practitioner, tune in Monday, August 15, 2011 at 12:00 pm (EDT), when the Northwest Regional Telehealth Resource Center co-hosts the CTeL Brown Bag Webinar, titled, “Are You a Medical Device Manufacturer: The FDA’s Final Rule on Medical Devices.”  This FREE Webinar features Anthony Pavel, JD, expert FDA […]

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CTeL’s July Brown Bag Webinar Write up

CTeL was pleased to have Dr. Felasfa Wodajo, MD, at Virginia Hospital Center and Rene Quashie, Esq. Regulatory Attorney for CTeL, speak at the July Brown Bag Webinar, titled, “mHealth: What are the Legal and Regulatory Barriers?”  Dr. Wodajo and Mr. Quashie gave an outstanding presentation on the compliancy issues that pertain to mobile medical […]

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FDA Releases Draft Guidance Report on Mobile Medical Apps

The U.S. Food and Drug Administration (FDA) released it’s draft guidance report on mobile medical applications.  The report, which pertains to mobile platforms such as smart phones, tablet computers, and personal digital assistants or “PDAs,” examines mobile medical applications for potential medical risks.  In an effort to help practitioners fully understand the FDA’s draft report, CTeL has prepared an executive summary […]

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CMS Isssues Credentialing and Privileging Memo to State Survey Directors

The Survey and Certification Group of the Centers for Medicare and Medicaid Services (CMS) sent a memorandum to the State Survey Agency Directors with information regarding the implementation of the July 5th CMS rule on credentialing and privileging for telehealth practitioners in hospitals and critical access hospitals. Click Here for a copy of the CMS […]

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CTeL Brown Bag Webinar – mHealth: What are the Legal and Regulatory Barriers?

CTeL welcomes Dr. Felasfa Wodajo, MD and Rene Quashie, JD Are mobile health devices compliant with FDA and HIPAA regulations? How patients receive care has changed dramatically over the last several years.  Mobile health or “mHealth” is a great example of a radical change in patient care.  Unfortunately, current laws and regulations were not intended […]

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ALERT: CTeL Releases Sample Credentialing and Privileging Written Agreements; Solicits Questions from the Telemedicine Community on CMS Credentialing Privileging Rule

CTeL has released two sample agreements for use in compliance with the recent Centers for Medicare and Medicaid Services (CMS) Telehealth Credentialing and Privileging rule.  Click here to find Hospital to Hospital and Hospital to Telemedicine Entity agreements, along with other information on this CMS rule at CTeL’s Telehealth Credentialing and Privileging Resource Center. CTeL […]

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