Article3D Printing Updates: ExOne IPO, Antitrust, And NanoscribeA summary of important 3D printing updates, including micro- and nanoscale printing.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
Article50-State Survey Of Telehealth Insurance LawsAccess Evolution: Post-Public Health Emergency Advances in Telehealth Laws Make Seeking Medical Care Easier for Many...United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleAre You Up-To-Date On The State And Federal Legislation That Matters To Your Company?Congressional interest continues in the controversial topic of "gainsharing," a program in which hospitals establish a mechanism for sharing certain cost savings (e.g., from using less costly supplies or devices) with physicians. A provision for a gainsharing demonstration project is included in the Deficit Reduction Act of 2007 signed into law on February 8, 2006. United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleArkansas (Again!) Medical Board Approves Telemedicine RulesThe Arkansas State Medical Board on Thursday voted unanimously, for a second time, to pass Regulation 38 establishing key definitions for "store and forward technology" and "originating site."United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleATA Issues Final Clinical Guidelines For TelepathologyThe American Telemedicine Association released its new Clinical Guidelines for Telepathology this weekUnited StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleCalifornia And The NIH Partner On Precision Medicine InitativeThe National Institutes of Health (NIH) All of Us program is a national initiative aimed at personalizing health care for all Americans.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleCalifornia Expands Use Of Telehealth To Involuntary Commitment Evaluationsalifornia recently passed legislation that allows evaluations and assessments for involuntary psychiatric holds to be conducted using telehealth technology. California's Lanterman-Petris-Short Act...United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleCancer Moonshot Initiative Adds Precision Surgery EffortThe White House recently announced the Precision Surgery Initiative (PSI) as a "first-of-its kind Advanced Research Projects Agency for Health (ARPA-H) program to develop novel technologies"...United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleCMS Extends Delayed Enforcement Of The Good Faith EstimateOn Friday, December 2, 2022, the Centers for Medicare & Medicaid Services (CMS) issued an FAQ regarding the Good Faith Estimate (GFE) and Convening Provider/Facility requirements in the Federal No Surprises Act.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleCMS Intends To Modify EHR "Meaningful Use" Program RequirementsThe new rule would reflect recent developments in the industry, and progress toward program goals achieved since the Meaningful Use Program began in 2011.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleCMS Issues Final Rule Increasing Medicare Inpatient Hospital PaymentsOn August 1, 2006, CMS posted a final rule that makes a number of important changes to Medicare payments under the Hospital Inpatient Prospective Payment System ("IPPS"). United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleEvolving Healthcare Trends & Patents: Charting A Safe Course For Personalized MedicineRapid changes resulting from personalized medicine are transforming healthcare.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleExecutive Gun Control Actions Result In HIPAA ModificationsIn response to the Obama Administration's executive actions to reduce gun violence, on January 4, 2016, the U.S. Department of Health and Human Services' Office of Civil Rights (OCR) issued a final rule...United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleExploring Regulatory Hurdles: How To Navigate FDA Approval For AI-Enabled Medical DevicesThis article provides an overview of the FDA's approval process for AI-enabled Software-as-a Medical-Device (SaMD). Under the current regulation regime, there are three pathways...United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleFDA Approves Companion Dx For PD-1 InhibitorAccording to the American Cancer Society ("ACS"), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer).United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleFederal Circuit Denies Rehearing In SequenomThe Federal Circuit has denied the petition for rehearing en banc in Ariosa Diagnostics, Inc. v. Sequenom, Inc., despite the filing of twelve amicus briefs in support of the petition.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleFTC Launches New Digital Health App ToolIn a follow up to the FTC's Mobile Health Best Practices Guide published in December 2022, the FTC has now launched a Mobile Health App Interactive Tool.United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleGeorgia Finalizes New Telemedicine Practice RulesThe Georgia Composite Medical Board recently finalized a new amendment to its telemedicine practice standards. The purpose of the amendment was to address the use of technology as it...United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP
ArticleHappy New Year! Potential Changes To HIPAA Requirements On The HorizonOn December 12, 2018, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), requested public comments on potential changes to the Health Insurance Portability and Accountability Act's regulations (HIPAA) that are perceived to be burdensome by the industry. United StatesFood, Drugs, Healthcare, Life SciencesFoley & Lardner LLP