On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements...more
On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more
Florida has a new law as of July 1, 2023 relating to the storage of certain health records. The newly enacted Florida Statutes section 408.051 creates the “Florida Electronic Health Records Exchange Act.” The Act states in...more
The Department of Health and Human Services ("HHS") has proposed amendments to the Confidentiality of Substance Use Disorder Patient Records Rule, 42 C.F.R. part 2 (the "Part 2 Rule") with a comment deadline of January 31....more
While the Office of the National Coordinator for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the ONC Health IT Certification Program (Information Blocking...more
In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more
On December 10, 2020, the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR) collaborated on announcing proposed HIPAA changes, intended to “empower patients” and “improve coordination of...more
Why It Matters - In order to safeguard their information, health care and life science organizations should remain vigilant in monitoring DHCoE developments and initiatives, including any policy/regulation clarifications...more
Aimed at enabling greater patient access and mandating interoperability, recent Final Rules from the Office of the National Coordinator for Health IT (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) have put...more
A patient asks her doctor to send her test results to an app the patient has downloaded on her phone. The doctor worries that the app is not secure and that the patient might not understand the security risks. What should...more
On March 9, 2020, the U.S. Department of Health and Human Services (HHS) published final rules to implement the information blocking prohibitions of the 21st Century Cures Act (Information Blocking Rules). The Information...more
In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of...more
CMS Regulation - CMS and ONC Unveil Proposals Transforming Interoperability and Patient Access to Data - The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health...more
On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance...more
This past Friday, the Office of Civil Rights within the U.S. Department of Health and Human Services published a formal Request for Information on Modifying HIPAA Rules to Improve Coordinated Care. The RFI’s publication...more
Management of electronic health records (EHR) is a complicated yet necessary task in the modern practice of medicine. To reduce the administrative burden of managing EHR records, many physicians and other healthcare...more
Uncertain. What better word to describe a year in which a new administration came to power and began to chart a new course for health policy, the fate of the Affordable Care Act (ACA) hung in the balance, and courts grappled...more
A recently unsealed qui tam action further demonstrates the growing focus on the propriety of incentive payments made under Medicare and Medicaid's Electronic Health Records (EHR) Incentive Programs. Health care providers...more
Following the frequent and varied ransomware attacks on health care entities over the past few years, the Office for Civil Rights (OCR) published guidance last summer to the health care industry reminding it that a ransomware...more
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
Healthcare providers excel at providing care to their patients, not designing IT strategies. Even so, with the trend toward value-based payments increasing, more healthcare providers have turned to electronic health records...more
With expenditures of over $ 3 trillion of market in the field of health care in the United States is huge. Incentives of the Federal Government for the introduction of electronic medical records resulted increasingly in the...more
The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more
The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, contains extensive rules designed to limit access by non-health plan entities to certain individually identifiable health...more
On January 7, 2016 the Department of Health and Human Services (“HHS”) released a fact sheet and a series of frequently asked questions to help to clarify an individual’s right to access and obtain a copy of his or her health...more