New, or newly interpreted, state laws and court decisions governing abortion may directly affect access to medical care and treatment for patients who are, or who want to become, pregnant. They also have potential...more
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket review of Laboratory Developed Tests...more
In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have implemented significant changes to...more
On Monday, March 16, 2020, Florida’s Surgeon General issued a rare Emergency Order (the Order) that allows certain out-of-state health care professionals to temporarily provide telehealth services to persons in Florida in...more
3/18/2020
/ Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Florida ,
Health and Safety ,
Health Care Providers ,
Infectious Diseases ,
Medicaid ,
Patient Access ,
Public Health ,
Surgeon General ,
Telehealth ,
Telemedicine
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
On May 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued draft manual guidance for surveyors evaluating whether hospitals that are co-located with other hospitals (or with other health care entities) meet the...more
From mobile apps for monitoring medications to virtual appointments with specialists, telehealth services are creating new levels of convenience for providers and patients. But as companies digitize more pieces of the health...more
Through several recently published rules, the Centers for Medicare & Medicaid Services (CMS) is making it possible for Medicare beneficiaries to have greater access to health care services provided remotely through telehealth...more
Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning.
Everything from healthtech to self-driving vehicles, to education and smart homes, drones and space, social...more
4/4/2018
/ Antitrust Provisions ,
Artificial Intelligence ,
Asia Pacific ,
Connected Cars ,
Connected Items ,
Drones ,
Ethics ,
Export Controls ,
FinTech ,
Intellectual Property Protection ,
Life Sciences ,
Outer Space ,
Popular ,
Regulatory Oversight ,
Robotics ,
Satellites ,
Smart Devices ,
Unmanned Aircraft Systems
On Friday, March 16, Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests for Medicare beneficiaries with advanced cancer.
...more
The recently enacted Bipartisan Budget Act of 2018 expands Medicare’s coverage for telehealth services in several ways. Inclusion of these provisions, which had been part of a Senate bill called the CHRONIC Care Act, is...more
On 14 April 2017, the Centers for Medicare & Medicaid Services (CMS) published the fiscal year (FY) 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective...more