sábado, 29 de abril de 2017

ONC Health IT Certification Program Updates (04/28/2017)

HealthIT.gov Banner

ONC Health IT Certification Program Updates (04/28/2017)

IN THIS ISSUE

Test Method Updates
Recently Updated Test Procedures (TPs)
2015 Edition Test Procedures (TPs)
Criterion Number
Criterion Title
Details
§ 170.315(b)(1)
Transitions of Care
  • Reformatted the transport test steps for readability. The System Under Test (SUT) aligns closer to the to the Test Lab Verification (TLV) columns.
    • Several numbering and narrative formatting changes.
    • Test numbering included on both the SUT and TLV sides.
  • Addition of alternative SUT Connection – Systems may not be connected using TLS and SASL or a “secure network”. Additional updates were made to indicate which tests were required only for the TLS and SASL alternative throughout the test procedure (See updated test case decoupling below). As part of this update the ordering of the test steps were altered to make them consistent throughout the test procedure.
  • Updates to test procedure were made to reflect decoupling of the TSL and SASL from the send/receive test cases corresponding to the changes made in the Edge Testing Tool (ETT). This includes the following changes:
    • SMTP Test (1-8, 14) included TLS, SASL and SMTP Send. The new test cases are SMTP Test 8 StartTLS, SMTP Test 14 SASL and SMTP Test 18 SMTP Send.
    • SMTP Test (9, 16, 20) included TLS, SASL and SMTP Receive. The new test cases are SMTP Test 9 StartTLS, SMTP Test 16 SASL and SMTP Test 20 SMTP Receive.
    • IMAP Test (19, 20,24) included TLS, SASL and IMAP Receive. The new test cases are IMAP Test 19 StartTLS, IMAP Test 20 SASL and IMAP Test 20 IMAP Receive (new test step).
    • POP Test (19, 20,24) included TLS, SASL and IMAP Receive. The new test cases are POP Test 19 StartTLS, POP Test 20 SASL and IMAP Test 20 POP Receive (new test step).
  • Removed the following test cases to reduce the burden of Edge testing: XDR MT Test 19, XDR MT Test 48, XDR MT Test 50a and 50b, SMTP MT Test 17, SMTP MT Test 18, SMTP Test 47 and Test 47a, SMTP Test 10, SMTP Test 11, SMTP Test 13
  • Removed negative connection test steps SMTP Test 22, documentation of negative authentication due to an invalid DIGEST-MD5 value,
  • Updated the link to the ETT
§ 170.315(g)(1)
Automated Numerator Recording
Modified language on which systems need to test for each calculation method. Modified language to clarify that health IT developers are not required to test steps 2a, 2b, and 2c and 4a, 4b, and 4c.

Recently Updated Test Data
2015 Edition Test Data
Criterion Number
Criterion Title
Details
§ 170.315(g)(1)
Automated numerator recording
(Eligible Provider/Eligible Clinician (EP/EC) Test Data)
Removed the requirement to calculate data for a Taxpayer Identification Number (TIN)/ National Provider Identifier (NPI) combination at a group TIN level.  Removed Scenario 2 from Required Tests 2a, 2b, 2c, and 3.
§ 170.315(g)(2)
Automated measure calculation
(EP/EC Test Data)
Modified Column I Row 50 in Required Test 2b to indicate No.

Recently Updated Certification Companion Guides (CCGs)
2015 Edition Certification Companion Guides (CCGs)
Criterion Number
Criterion Title
Details
§ 170.315(a)(4R
Drug-drug, drug-allergy interaction checks for CPOE
Revised upon further analysis of the privacy and security (P&S) Framework framework and the applicability of the “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(a)(9)
Clinical decision support
Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(a)(10)
Drug-formulary and preferred drug list checks
Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(a)(13)
Patient-specific education resources
Revised as a result of further analysis of the applicability of the 2015 Edition “amendments” certification criterion (§ 170.315(d)(4)) to health IT capabilities that would not necessarily have any patient data for which a request for an amendment would be relevant.
§ 170.315(c)(4)
Clinical quality measures – filter
Revised to clarify the requirements for filtering by SNOMED CT® codes for problem list data.
§ 170.315(g)(1)
Automated Numerator Recording
Added clarification on Health IT Module’s capability requirements on recording TIN/NPI combinations. Added clarification on confirmation of receipt of a Consolidated Clinical Document Architecture (C-CDA) by a receiving provider prior to incrementing the numerator. Added links to measure-specific guidance.
 
§ 170.315(f)(7) Transmission to public health agencies – health care surveys
In support of the Centers for Disease Control National Center for Health Care Statistics mission and in response to industry feedback, ONC will permit testing and certification for § 170.315(f)(7) to conformance of HL7 CDA® R2 Implementation Guide (IG): National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realmas part of the 2015 Edition certification. The Release 1.2 test tool is currently being developed and expected to be completed summer 2017. We encourage developers to work with their ONC-Approved Testing Laboratories (ONC-ATL) for pilot testing and to provide feedback of the Release 1.2 beta test tool which is currently available at http://cda-validation.nist.gov/cda-validation/muNHCS12.html.
Products already certified to IG Release 1.0 prior to the availability and switch over to the Release 1.2 test tool will not be required to retest or recertify to release 1.2. Updates to the Certification Companion Guide (CCG) with additional details are forthcoming.
New ONC Regulation FAQ (#51)
ONC has released a new FAQ providing clarification for instances in which a voluntary consensus standards organization (or steward) issues a correction to a standard or implementation specification after it has been adopted by ONC in the final rule. FAQ #51 can be found on the ONC Regulations FAQs page.
Edge Test Tool Update
On April 25, 2017, the Edge Test Tool (ETT) release 1.2.4.1 was deployed with the following changes:
Please note that the old links will no longer be accessible.
  • The C-CDA validator updates for the release include defect fixes to the Reference C-CDA content validation for
    • Care Plan documents submitted for § 170.315 (b)(9)
    • Clinical Information Reconciliation and Incorporation (CIRI) documents submitted for § 170.315 (b)(2); and
    • Data Segmentation for Privacy (DS4P) documents submitted for § 170.315 (b)(7).
Certified Health IT Product List (CHPL) Updates
The CHPL now reports all “identifiable surveillance.” Under the ONC Health IT Certification Program: Enhanced Oversight and Accountability final rule (81 FR 72404) all identifiable surveillance results, results where no non-conformities are determined, must be publically available on the CHPL on a quarterly basis to provide stakeholders with a more readily available means for accessing surveillance results. Results where non-conformities are determined will still be updated weekly as required.
 For additional information on the 2015 Edition requirements, please visit https://www.healthit.gov/policy-researchers-implementers/2015-edition-final-rule
Questions may be directed to the ONC Health IT Certification Program via email at: ONC.Certification@hhs.gov  

What's New at CBER Update

What's New at CBER Update

New FDA Logo Blue

This page has been updated recently.

Registration is Open: NIST-DHS Standards for Pathogen Detection for Biosurveillance and Clinical Applications Workshop (Aug. 14-15, 2017)

NIST

Registration is Open:

Standards for Pathogen Detection

Join us on August 14-15, 2017 for the NIST-DHS Standards for Pathogen Detection for Biosurveillance and Clinical Applications Workshop. The purpose of this workshop is to present state-of-the-art pathogen detection technologies, emphasizing the need for standards relevant to the clinical diagnostic and biothreat detection stakeholder communities. Speakers will include subject matter experts from industry, academia, and government.
Join our Twitter Chat using: #NISTPathogen


Register Now

The Affordable Care Act Federal Upper Limits Have Been Updated

Medicaid.gov
The updated Affordable Care Act Federal upper limits (FUL) calculated in accordance with the Medicaid Covered Outpatient Drug final rule with comment are now available on the Medicaid.gov website at https://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Pharmacy-Pricing.html.  States will have up to 30 days from the May 1, 2017 effective date to implement these updated FULs.  
For further information on the FUL program, please see the Federal Upper Limits page athttps://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/federal-upper-limits.html.

MMWR Vol. 66 / No. 16

MMWR Logo

MMWR Weekly
Vol. 66, No. 16
April 28, 2017



In this report
Workers Memorial Day — April 28, 2017

The figure above is a photograph showing oil workers at a derrick at dusk.
Work-related injuries claimed the lives of 4,836 workers in the United States in 2015.

Announcement | MMWR

Announcement | MMWR
MMWR Logo

MMWR Weekly
Vol. 66, No. 16
April 28, 2017


Announcement: Community Preventive Services Task Force Recommends Interventions to Increase Healthier Foods and Beverages in Schools

The Community Preventive Services Task Force recently posted new information about four findings on its website: 1) Obesity: Meal and Fruit and Vegetable Snack Interventions to Increase Healthier Foods and Beverages Provided by Schools*; 2) Obesity: Supporting Healthier Snack Foods and Beverages Sold or Offered as Rewards in Schools; 3) Obesity: Multicomponent Interventions to Increase Availability of Healthier Foods and Beverages in Schools§; and 4) Obesity: Increasing Water Access in Schools. ¶
Established in 1996 by the U.S. Department of Health and Human Services, the task force is an independent, nonfederal panel of public health and prevention experts whose members are appointed by the director of CDC. The task force provides information for a wide range of persons who make decisions about programs, services, and other interventions to improve population health. Although CDC provides administrative, scientific, and technical support for the task force, the recommendations developed are those of the task force and do not undergo review or approval by CDC.
 Top
 Top
Suggested citation for this article: Announcement. Community Preventive Services Task Force Recommends Interventions to Increase Healthier Foods and Beverages in Schools. MMWR Morb Mortal Wkly Rep 2017;66:428. DOI: http://dx.doi.org/10.15585/mmwr.mm6616a7.

MMWR Vol. 66 / No. 16 ► Announcement: ALS Awareness Month — May 2017

Announcement: ALS Awareness Month — May 2017 | MMWR

MMWR Logo

MMWR Weekly
Vol. 66, No. 16
April 28, 2017



PDF of this issue

Announcement: ALS Awareness Month — May 2017


May is ALS Awareness Month, observed to raise awareness of and foster research for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. ALS is a progressive, fatal, neurodegenerative disorder of upper and lower motor neurons. The cause of ALS is not known, and no cure exists.
In October 2010, the Agency for Toxic Substances and Disease Registry (ATSDR) launched the congressionally mandated National ALS Registry (https://wwwn.cdc.gov/als/) to collect and analyze data regarding persons in the United States with ALS. The goals of the registry are to determine the incidence and prevalence of ALS, characterize the demographics of persons living with ALS, and examine possible risk factors for the disease.
In August 2016, ATSDR released its second prevalence report, which indicated an estimated 16,000 persons (5.0 per 100,000 population) were living with ALS in 2013. ALS remains more common among whites, males, non-Hispanics, and persons aged 60–69 years. The registry uses data from existing national databases, as well as the registry’s online system to track ALS cases. Online registrants can also take surveys regarding potential risk factors for the disease.
A new National ALS Biorepository allows researchers to request high-quality biologic specimens to study ALS. Both in-home and postmortem specimens are being collected from interested patients enrolled in the National ALS Registry. Epidemiologic data from patient surveys will be matched with patient specimens, making the biorepository a rich data source for ALS research.
ATSDR is collaborating with the ALS Association (https://www.alsa.org), the Muscular Dystrophy Association (https://www.mda.org), the Les Turner ALS foundation (http://www.lesturnerals.org), and other organizations to spread awareness about the National ALS Registry. Additional information is available at https://www.cdc.gov/als.
 Top
Suggested citation for this article: Announcement: ALS Awareness Month — May 2017. MMWR Morb Mortal Wkly Rep 2017;66:428. DOI: http://dx.doi.org/10.15585/mmwr.mm6616a6.