On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more
President Joe Biden was sworn into office on January 20, 2021. As with any incoming administration, new policies will be pursued while those of the previous administration are furthered, abandoned, or undone. The federal...more
3/1/2021
/ Biden Administration ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Physicians ,
Popular
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...more
On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) released an updated version of its "Code of Ethics on Interactions with U.S. Health Care Professionals" (HCPs) (the Code), which will take effect on...more
Over the counter (OTC) drugs are medicines sold directly to consumers without a prescription from a healthcare professional. Traditionally, the range of OTC drugs has been limited to medical diseases and conditions for which...more
Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) -
Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more
6/1/2018
/ Colleges ,
Digital Health ,
Due Diligence ,
Health Care Providers ,
Intellectual Property Protection ,
IP License ,
Joint Venture ,
Medical Devices ,
Partnerships ,
Software Developers ,
Technology Sector ,
Universities ,
Venture Capital
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
Machine Learning and Digital Health Applications -
The use of artificial intelligence (AI) algorithms to solve complex problems has risen dramatically in the last several years. In 2017, Gartner identified more than 1,000...more
3/9/2018
/ Digital Health ,
Health Care Providers ,
Innovative Technology ,
Life Sciences ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Data ,
PHI ,
Section 101
Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more
12/22/2017
/ Apple Watch ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Medicare ,
Mobile Apps ,
Telemedicine
Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more
11/9/2017
/ 21st Century Cures Act ,
Acquisitions ,
Digital Health ,
Emerging Growth Companies ,
Emerging Technology Companies ,
Health Care Providers ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Software ,
Trade Secrets ,
Warranties ,
Wearable Technology
Factoring in Human Factors -
According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more