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Legislative Update

Insight 3rd quarter 2018
Legislative Report

Greetings,

As the 2018 statewide elections draw close, I am pleased to share with you that FOA has worked strategically and diligently to ensure that YOU will have a clear voice in Florida Politics.  On a daily basis, FOA works as an advocate for patient safety and access to affordable eye health care, while continuously defending our profession.  This entire process is made possible solely thru your membership in FOA, support from our Industry Relations partners and your contributions to ODEYEPAC and FLOPAC.  On behalf of FOA, I thank you kindly for your trust and continued support.

Now, on with the update:

Telemedicine Versus On-Line Refraction Only Eye Tests

Telemedicine that promotes appropriate eye health care will likely be addressed in the 2019 Florida Legislative session.  Language put forth in the past may resurface such as: 

“Telemedicine” means the practice by a licensed Florida physician or physician assistant where patient care, treatment, or services are provided through the use of medical information exchanged from one site to another via electronic communications. Telemedicine shall not include the provision of health care services only through an audio only telephone, email messages, text messages, facsimile transmission, U.S. Mail or other parcel service, or any combination thereof.

(2) The standard of care, as defined in Section 456.50(1)(e), F.S., shall remain the same regardless of whether a Florida licensed physician or physician assistant provides health care services in person or by telemedicine.

(3) Florida licensed physicians and physician assistants providing health care services by telemedicine are responsible for the quality of the equipment and technology employed and are responsible for their safe use. Telemedicine equipment and technology must be able to provide, at a minimum, the same information to the physician and physician assistant which will enable them to meet or exceed the prevailing standard of care.

This is in contrast to “on-line refraction only" eye exams such as "Opternative" that continues "to operate" in the face of a challenge from the FDA in the form of a cease and desist order:

According to Medscape in late 2017 "The US Food and Drug Administration (FDA) has told Opternative Inc to stop marketing its mobile eye examination app, saying the company has not applied for marketing clearance or approval of the medical device and is in violation of the Federal Food, Drug, and Cosmetic Act.  The FDA sent a warning letter to Chicago-based Opternative Inc on October 30, 2017, giving the company 15 days to respond in writing with specific steps it would take to comply with the FDA's requirements and how it would prevent similar violations in the future. The FDA just released the letter recently:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm600029.htm

I promise you that FOA will continue to keep you informed of these issues should any developments occur.  Most importantly, FOA is committed to QUICKLY engage in any and all legislation with regard to these issues and their potential impact on patient eye health and safety. In the meantime, please continue helping FOA thru "grass roots" support of your local candidates and please get out and vote in the upcoming election!

Best Regards,

Dr. Kenneth W. Lawson

FOA Legislative Chair

  

 

 

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