TAILIEUCHUNG - FDA REGULATION OF MOBILE HEALTH

Developing a reimbursement system for language services in Medicaid/CHIP has been expedited because these large programs have administratively determined reimbursement rules. For this reason, although language services for Medicaid/CHIP populations are reimbursed in Minnesota, no similar reimbursement process is required for commercial health plans, and establishing such a process is more complex because of the way health plans are paid. Currently, the expense of lan- guage services for commercially insured populations falls on providers. In recent years, legislation mandating that commercial health plans provide and pay for interpreter services was introduced in two legislative sessions but failed to pass because of. | fda REGULATION OF MOBILE health mobi health news 2010 REPORT Copyright June 2010 Chester Street Publishing Inc. All Rights Reserved. Contents 1 About the Author 2 Letter from the Editor 3 FDA May Regulate Certain Mobile Phones Accessories 6 Step-by-step FDA wireless health regulation 10 How to get FDA to clear a mobile health app I7 Should mHealth companies want FDA regulation 22 How to Avoid mHealth Regulation 29 Washington signals possible FDA regulation of mHealth 32 Will the FDA regulate mHealth care providers 37 The Dynamic Future of FDA Regulation of mHealth About the Author Bradley Merrill Thompson Bradley Merrill Thompson is a shareholder in the law firm of Epstein Becker Green . There he counsels medical device and other life science companies on a wide range of FDA regulatory reimbursement and clinical trial issues. At the firm Mr. Thompson leads the Medical Device Regulatory Practice the Clinical Trials Practice and the Connected Health Practice and serves on the firm s Health Life Sciences Steering Committee. For trade associations Mr. Thompson has served as counsel to AdvaMed for payment issues as General Counsel to the Combination Products Coalition and for 17 years as General Counsel and Secretary for the Indiana Medical Device Manufacturers Council. Connected Health Practice In EBG s Connected Health Practice Mr. Thompson focuses on the federal regulatory requirements FDA reimbursement privacy and others that impact remote monitoring mobile health HIT and device interoperability. The firm s Connected Health Practice brings together a multidisciplinary team of attorneys and consultants trained and experienced in Medicare and private insurance payment regulatory scientific IT clinical and security disciplines. Mr. Thompson serves as outside counsel to Continua Health Alliance conducts educational programs on connected health regulation and blogs for . Teaching Writing and Serving Mr. Thompson has taught food drug law at Indiana .

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