On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020. This joint announcement was made by the Office of the
Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private sectors. Prior to earning her law degree and Master of Public Affairs, she worked in the U.S. Senate for over four years, advising Senators John Breaux and Tom Carper on health and social policy matters. Ms. Jennings later handled federal health policy issues at WellPoint, Inc. During law school, she worked with the U.S. Office of Management and Budget during consideration of the Affordable Care Act, and with the Federal Trade Commission for then-Chairman Jon Leibowitz.
HHS Finalizes Interoperability Rules
On March 9, 2020, the Department of Health and Human Services (HHS) issued two final rules aimed at improving patient access to electronic health information (EHI), as well as the standardization of modes of exchange for EHI. The rules, which were issued by the Office of the National Coordinator for Health Information Technology (ONC) and…
Vote on HHS Secretary Nomination Expected as Early as this Week; Nomination Hearings Included Little Discussion of Health IT
The full Senate could vote as early as this week on the nomination of Rep. Tom Price (R-GA) to be Secretary of the U.S. Department of Health and Human Services (HHS). In January, two Senate Committees held hearings on Rep. Price’s nomination. These hearings focused largely on Rep. Price’s stance on repeal of the Affordable Care Act (ACA) and on reform of the Medicare and Medicaid programs. Senators asked few questions related to health information technology, and the limited discussion on this topic centered primarily on the burdens placed on providers by HHS initiatives to promote the “meaningful use” of electronic health records (EHRs). …
Continue Reading Vote on HHS Secretary Nomination Expected as Early as this Week; Nomination Hearings Included Little Discussion of Health IT
GAO Recommends that HHS Strengthen Privacy and Security Guidance and Oversight
Earlier this week the Government Accountability Office released a report critiquing the U.S. Department of Health and Humana Services’ (HHS) oversight of and guidance related to health information security and privacy. (The report is available here.)
GAO cited the increasing incidence of hacking and other breaches, which affected over 113 million health records in 2015, as a key reason to ensure that HHS provides appropriate guidance to and oversight of covered entities and business associates. Hacking and other breaches may result in identify theft, fraud, disruption of health care services, and even national security threats.
GAO’s concerns fell into two primary categories: those related to HHS’s guidance to covered entities and business associates, and those related to oversight efforts.
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ONC Report to Congress Identifies Gaps in Oversight of Privacy and Security of mHealth Technologies and Health Social Media
Earlier this month the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), released a report to Congress highlighting “large gaps” in policies and oversight surrounding access to and security and privacy of health information held by certain “mHealth technologies” and “health social media.”
Senate HELP Committee Marks Up Precision Medicine, Other “Cures” Bills
Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a final mark-up of legislation comprising the Committee’s counterpart to the House-passed 21st Century Cures Act. The HELP Committee approved five bills including S. 2713 to advance the development of “precision medicine” through research and data sharing. We have reported on the President’s precision medicine initiative in other posts available here. …
Continue Reading Senate HELP Committee Marks Up Precision Medicine, Other “Cures” Bills
FDA Regulatory Science Priorities Address Use of Data, Health Information Technology
On October 20, 2015, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its top ten Regulatory Science Priorities for FY 2016 to facilitate improvements in the safety and effectiveness of medical devices and accelerate innovation. Several of the priorities would harness health information technology or health data to improve regulatory decision making, such as by:
- Leveraging “Big Data” warehouses such as the human genome sequence database and clinical trials databases. CDRH notes that these sources are “underutilized in regulatory decision making” and could “streamlin[e] scientific review and identif[y] potential emergency post-market issues earlier in the process.”
- Researching ways to improve device cybersecurity and enhance the performance of devices, including through interoperability and an understanding of how software modifications impact device performance.
- Leveraging evidence from clinical experience, such as after-marketing observational data in healthcare databases.
- Developing and validating instruments for collecting and using patient experience data and patient reported outcome measures (PROMs).
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Proposed Rule Would Amend Federal “Common Rule” Requirements
Today, we published a post on our InsidePrivacy blog regarding a proposed rule to amend federal Common Rule requirements. The proposal includes a number of changes related to privacy and data security and other changes relevant to entities seeking to conduct secondary research using collected data.
Senate Approves Bill to Ease Meaningful Use Requirements In Ambulatory Surgery Setting
Last week, the U.S. Senate unanimously approved a bill that would ease federal requirements that professionals seeing patients at ambulatory surgery centers (ASCs) “meaningfully use” certified electronic health records (EHRs). The measure would sunset after certified EHR technology is applicable to the ASC setting.
Continue Reading Senate Approves Bill to Ease Meaningful Use Requirements In Ambulatory Surgery Setting
CMS Releases Additional Medicare Data; Expands Access to Data for “Commercial” Purposes
Last week, the Centers for Medicare & Medicaid Services (CMS) made additional Medicare data publicly available and expanded the permissible uses of other data.
For the third consecutive year, CMS released hospital-specific data on inpatient and outpatient charges, Medicare payments, and utilization for common Medicare procedures. CMS also released similar data on physicians and other…