Background: Issuing Florida’s Emergency Order -
On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast...more
On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things,...more
Artificial intelligence (AI) systems have raised concerns in the public—some speculative and some based in contemporary experience. Some of these concerns overlap with concerns about privacy of data, some relate to the...more
3/4/2020
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Comment Period ,
Data Privacy ,
Executive Orders ,
Health Care Providers ,
Life Sciences ,
OMB ,
Regulatory Agenda ,
Research and Development ,
Rulemaking Process ,
Technical Standards
As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged...more
When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity...more
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more
2/4/2020
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CEHRT ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Health Care Providers ,
Information Technology ,
Medical Research ,
Patient Privacy Rights ,
PHI ,
Strategic Planning ,
Technology ,
Value-Based Care
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many...more
Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
2/6/2019
/ ACOs ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Health Record Incentives ,
Enforcement Actions ,
Health Care Providers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
OIG ,
Popular ,
Regulatory Reform ,
Request For Information ,
Telehealth ,
Telemedicine
As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program. Both regulatory and statutory changes have expanded reimbursement opportunities and,...more
Across the health care sector, telemedicine is naturally and strategically being integrated into health care delivery and treatment plans as targeted and efficient solutions to specific health issues by hospitals, medical...more
Nationalism and Cross-Border M&A: Navigating Populist Politics in Deal Making -
More than half of the G20 countries voted-in campaigns that focused on harming foreign, outside interests as a means to strengthen domestic...more
9/5/2017
/ ACOs ,
Acquisitions ,
Arbitration ,
Arbitration Awards ,
Artificial Intelligence ,
China ,
Customer-Loyalty Programs ,
Data Breach ,
Data Controller ,
Data Privacy ,
Due Diligence ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Hospitals ,
India ,
Joint Venture ,
Long-Term Investment Funds ,
Mergers ,
Personal Data ,
Shareholders ,
UK
Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s...more
Artificial Intelligence (AI) is everywhere these days, and the health care sector is no exception. While AI in health care delivery is no longer new, recent advances in AI systems increase the likelihood that we will have to...more
Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, which removes the controversial “face-to-face” or in-person consultation requirement to establish a...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency
President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...more
The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care...more
Introduction -
The transition of the US health care payment system from fee-for-service (FFS) to alternative value-based, budget-based, episode or procedure-based (e.g., bundled) and/or population-based payment models...more
For many decades, at least since the passage of the Health Maintenance Organization Act of 1973, there have been reform efforts focused on moving the United States health care system away from fee-for-service (FFS)...more
As we enter into the new year, the health industry continues to see expanded access to telehealth services. After a whirlwind 2015 in which we saw over 200 telehealth-related bills introduced in 42 states, New York and...more