Department of Health and Human Services March 3, 2016 – Federal Register Recent Federal Regulation Documents

Privacy Act of 1974; Effective Date-April 2, 2016; Expiration Date-October 2, 2017
Document Number: 2016-04735
Type: Notice
Date: 2016-03-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the Department of Veterans Affairs, Veterans Health Administration (VHA).
Privacy Act of 1974; CMS Computer Match No. 2016-07; HHS Computer Match No. 1602; Effective Date-April 2, 2016; Expiration Date-October 2, 2017
Document Number: 2016-04734
Type: Notice
Date: 2016-03-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the Defense Enrollment Eligibility Reporting System (DEERS), Defense Manpower Data Center (DMDC), Department of Defense (DoD).
Privacy Act of 1974; CMS Computer Match No. 2016-11; HHS Computer Match No. 1601; Effective Date-April 2, 2016; Expiration Date-October 2, 2017
Document Number: 2016-04732
Type: Notice
Date: 2016-03-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the State-based Administering Entities.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2016-04674
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-04673
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-04672
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Meeting
Document Number: 2016-04671
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-04630
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-04629
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting
Document Number: 2016-04628
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services, National Institutes of Health
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Consumer Health Data Aggregator Challenge”
Document Number: 2016-04596
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services
The Consumer Health Data Aggregator Challenge is intended to spur the development of third-party, consumer-facing applications that use open, standardized Application Programming Interfaces (APIs) to help consumers aggregate their data in one place and under their control. This challenge will focus on solving the problem that many consumers have todaythe ability to easily and electronically access their health data from different health care providers using a variety of different health IT systems. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Effective Date of Requirement for Premarket Approval for Blood Lancets
Document Number: 2016-04579
Type: Proposed Rule
Date: 2016-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device.
General and Plastic Surgery Devices; Reclassification of Blood Lancets
Document Number: 2016-04578
Type: Proposed Rule
Date: 2016-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information.
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Provider User-Experience Challenge”
Document Number: 2016-04466
Type: Notice
Date: 2016-03-03
Agency: Department of Health and Human Services
Like the Consumer Health Data Aggregator Challenge, the Provider User-Experience Challenge incents the development of applications for health care providers that use open, standardized APIs to enable innovative ways for providers to interact with patient health data. This challenge will focus on demonstrating how data made accessible to apps through Application Programming Interfaces (APIs) can positively impact providers' experience with EHRs by making clinical workflows more intuitive, specific to clinical specialty, and actionable. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).