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
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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
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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
Where Things Stood -
Understanding the impact of what we have seen so far this year first requires an understanding of where we were at the end of 2017, with respect to both Medicare reimbursement and provider adoption of...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
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
A recent article in Kaiser Health News highlights the health risks associated with the increased effort to get patients home—namely, the need for families to gain and effectively deploy the skills needed to care for...more
A lot of us have argued that one of the floodgates for telemedicine has been reimbursement. If states and the Federal government more liberally reimbursed or required reimbursement for telemedicine service, we argue then a...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
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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
McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...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 promise of health care reform by the incoming administration will result in significant changes; but understanding how those changes may flow through to digital health industry requires an analytic framework that...more
Overview of the Proposed Reforms of the EU Merger Control Regime -
In October 2016, the European Commission launched a public consultation to continue the process of identifying possible areas of the EU Merger Regulation...more
12/5/2016
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Acquisitions ,
Arbitration ,
Chile ,
China ,
Competition ,
Defend Trade Secrets Act (DTSA) ,
EU ,
European Merger Control Regulation ,
Foreign Investment ,
Healthcare ,
Member State ,
Mergers ,
Shareholders ,
Statute of Limitations ,
Trade Secrets
Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December...more
The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more
One of the most talked about topics when it comes to digital health is the reimbursement under various third-party payer programs. Most notably, telemedicine and remote monitoring have received a lot of attention, and the...more
Summary -
The Centers for Medicare and Medicaid Services (CMS) released its CY2017 Physician Fee Schedule Proposed Rule on July 17 - after receiving requests from various stakeholders to add telehealth services as...more