Health Information Technologies

News & Analysis as of

What's "Hidden" in the 21st Century Cures Act for Health Care Entities

The 21st Century Cures Act (Cures) was signed into law December 13, 2016. While the primary focus of the 996-page Act centered on biomedical innovation, several components of Cures have significant implications for health...more

42 C.F.R. Part 2 Final Rule Is Officially Delayed … Can Comments to HHS and OMB Fix It?

On January 18, 2017, the U.S. Department of Health and Human Services (HHS) published a final rule amending the Confidentiality of Substance Use Disorder Patient Records rule at 42 C.F.R. Part 2. Yesterday, HHS delayed the...more

21st Century Cures: A Closer Look

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

EEOC issues guidance on new wellness notice mandated for 2017

Effective as of the first day of the plan year that began on January 1, 2017, or after, employers maintaining wellness programs that collect employee health information must satisfy a new notice requirement. The EEOC has...more

The 21st Century Cures Act

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

21st Century Cures Act: Key Provisions of Interest to Drug/Device Clients

Included in the many provisions contained in the 21st Century Cures Act are ones addressing drug, device, and biologic development and approval. Topics include the use of “real world evidence” in regulatory approvals, drug...more

Rx IP Update - December 2016

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

21st Century Cures Act – Provisions Relating to Digital Health

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). While much of the focus has been on policies intended to accelerate drug and device development and approval, the Cures Act also...more

2016 Health IT Leadership Summit Insights

On December 7, 2016, lawyers from Arnall Golden Gregory LLP’s Healthcare Technology team attended the annual Health IT Leadership Summit. While there, we noted several overarching themes. At the forefront were the topics of...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Trump’s Impact on Digital Health: An Analytic Framework for Evaluating the Changing Landscape

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

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

10 Things You Need to Know About Health Care Bankruptcies in 2017

The coming year will likely continue to be a tumultuous year for health care providers, suppliers, and payers, as they adapt to meet new challenges and market forces, particularly in light of the open questions as to the...more

The U.S. Department of Health and Human Services Publishes Two Free Resources to Help Practices Navigate Healthcare IT

The U.S. Department of Health and Human Services (“HHS”), Office of the National Coordinator (“ONC”) has published two free online playbooks to assist healthcare providers navigate healthcare information technology (“IT”)....more

2016 Security of Things® Forum

The third annual Security of Things® Forum (SECOT) in Cambridge, Massachusetts fostered discussion on a variety of cyber-security related topics ranging from a standards-based approach to security connected devices to...more

Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and...

INTRODUCTION - Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the...more

ONC Revises Health IT Certification Program Requirements

The HHS Office of the National Coordinator for Health Information Technology (ONC) has adopted a final rule to enable the ONC to directly review certified health information technology (IT) to determine whether it conforms to...more

A Stick to Balance the Carrot: ONC Finalizes a New Framework to Address Non-Conformities in Certified Health Information...

The Office of the National Coordinator for Health Information Technology (ONC) has released a final rule (Final Rule) introducing a new regulatory framework for certified health information technology (Health IT). The use of...more

OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

ONC Releases Enhanced Regulatory Requirements to Improve Transparency for Health Information Technology Products

The Office of the National Coordinator for Health Information Technology (“ONC”) has operationalized regulatory requirements to improve transparency in health information technology (“health IT”). The regulations, which were...more

Managing the Transition to Transformation: Provider/Payor Integration: 2016 Is Not the 1990s

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

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

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