Authorized Certification Body - Revision history

Tomjones: /* References */

2020-11-10T23:44:06Z

References

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	* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule] (2020-05-01)		* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule] (2020-05-01)
	* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.		* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.
	* [https://www.~~hhs~~.gov/~~about/news~~/2020~~/10/30/~~federal-health-it-strategic-plan~~-supports-patient-access-to-their-own-health-information.html~~ ONC Strategic Plan] (2020-10-30)		* [https://www.healthit.gov/topic/2020-2025-federal-health-it-strategic-plan ONC Strategic Plan] (2020-10-30)

	[[Category: Profile]]		[[Category: Profile]]
	[[Category: Health]]		[[Category: Health]]

Tomjones: /* References */

2020-11-10T23:42:45Z

References

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	* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule] (2020-05-01)		* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule] (2020-05-01)
	* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.		* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.
			* [https://www.hhs.gov/about/news/2020/10/30/federal-health-it-strategic-plan-supports-patient-access-to-their-own-health-information.html ONC Strategic Plan] (2020-10-30)

	[[Category: Profile]]		[[Category: Profile]]
	[[Category: Health]]		[[Category: Health]]

Tomjones: /* Goals */

2020-11-10T23:21:31Z

Goals

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	# Allow certified mobile apps to assert its own assurance level to web sites on the internet.		# Allow certified mobile apps to assert its own assurance level to web sites on the internet.
	# Align with the evolving mobile driver’s license effort as source of identity proofing with minimal personal data disclosure (in cooperation with the Kantara PIMDL work group).		# Align with the evolving mobile driver’s license effort as source of identity proofing with minimal personal data disclosure (in cooperation with the Kantara PIMDL work group).
			# Improved portability of user data as well as the identity proofing and authencation of the user with the Patient Portal of the EHR.

	==Context==		==Context==

Tomjones: /* References */

2020-11-10T23:19:57Z

References

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	==References==		==References==
	* [https://www.healthit.gov/curesrule/ ONC’s Cures Act Final Rule supports seamless and secure access, exchange, and use of electronic health information]		* [https://www.healthit.gov/curesrule/ ONC’s Cures Act Final Rule supports seamless and secure access, exchange, and use of electronic health information]
	* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule]		* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule] (2020-05-01)
	* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.		* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.

	[[Category: Profile]]		[[Category: Profile]]
	[[Category: Health]]		[[Category: Health]]

Tomjones: /* References */

2020-11-10T23:19:24Z

References

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	* [https://www.healthit.gov/curesrule/ ONC’s Cures Act Final Rule supports seamless and secure access, exchange, and use of electronic health information]		* [https://www.healthit.gov/curesrule/ ONC’s Cures Act Final Rule supports seamless and secure access, exchange, and use of electronic health information]
	* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule]		* [https://www.healthit.gov/curesrule/download ONC's Cures Act Final Rule]
			* [https://www.hhs.gov/about/news/2020/10/29/hhs-extends-compliance-dates-information-blocking-health-it-certification-requirements-21st-century-cures-act-final-rule.html The interim final rule] (IFR) or HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule.

	[[Category: Profile]]		[[Category: Profile]]
	[[Category: Health]]		[[Category: Health]]

Tomjones: /* Solutions */

2020-11-10T23:15:09Z

Solutions

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	This solution for user apps is based on existing requirements of the ONC for the patient portal of an EHR. Since that EHR solution required a trust infrastructure, it is proposed to take a similar approach to user apps.		This solution for user apps is based on existing requirements of the ONC for the patient portal of an EHR. Since that EHR solution required a trust infrastructure, it is proposed to take a similar approach to user apps.
	* See the documentation on [https://www.healthit.gov/buzz-blog/healthit-certification/what-you-need-to-know-about-the-conditions-and-maintenance-of-certification What You Need to Know About the Conditions and Maintenance of Certification].		* See the documentation on [https://www.healthit.gov/buzz-blog/healthit-certification/what-you-need-to-know-about-the-conditions-and-maintenance-of-certification What You Need to Know About the Conditions and Maintenance of Certification].
	* It is assumed here that the most common patient device will be a smart phone but other devices like laptops and wearable or home medical devices will also be addressed in the future.		* It is assumed here that the most common patient device will be a smart phone but other devices like laptops and wearable or home medical devices will also be addressed in the future. The following are an expansion of the words of the IFR to make them more relevant to the user device application specifically.
	# Basis and Scope - while it does not appear to be clearly stated, the intent of 45 CFR (170 and 171) seems to apply to programmers of Health ID systems '''that reside in EHR's'''.		# Basis and Scope - while it does not appear to be clearly stated, the intent of 45 CFR (170 and 171) seems to apply to programmers of Health ID systems '''that reside in EHR's'''.
	## It is the intent of this effort to extend the certificate of compliance (CoC) to native apps running on smartphones with a [[Authorized Certification Body]] to include the Kantara Initiative.		## It is the intent of this effort to extend the certificate of compliance (CoC) to native apps running on smartphones with a [[Authorized Certification Body]] to include the Kantara Initiative.

Tomjones: /* Solutions */

2020-11-10T23:14:00Z

Solutions

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	# Information Blocking - there must be no action that constitutes information blocking. But this only applies to apps that are from certified developers.		# Information Blocking - there must be no action that constitutes information blocking. But this only applies to apps that are from certified developers.
	# The following communications must be provided for Health IT apps.		# The following communications must be provided for Health IT apps.
	## The user ~~support capability of~~ the app.		## The user ability using the app.
	## The interoperability of the APIs used by the app.		## The interoperability of the APIs used by the app. This applies to the identification proofing and authentication of the user as well as the compatibility with FHIR Rev 4.
	## The security of the user's private data in transit and at rest on the app.		## The security of the user's private data in transit and at rest on the app.
	## User experiences when patients or delegates use the app.		## User experiences when patients or delegates use the app.

Tomjones: /* Solutions */

2020-11-10T23:11:49Z

Solutions

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	# Information Blocking - there must be no action that constitutes information blocking. But this only applies to apps that are from certified developers.		# Information Blocking - there must be no action that constitutes information blocking. But this only applies to apps that are from certified developers.
	# The following communications must be provided for Health IT apps.		# The following communications must be provided for Health IT apps.
	## The user ~~ability~~ of the app.		## The user support capability of the app.
	## The interoperability of the APIs used by the app.		## The interoperability of the APIs used by the app.
	## The security of the user's private data in transit and at rest on the app.		## The security of the user's private data in transit and at rest on the app.
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	* from 42 CFR 170.523 (k)(1) (i)		* from 42 CFR 170.523 (k)(1) (i)
	“This Health IT Module is [specify Edition of health IT certification criteria] compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.”		“This Health IT Module is [specify Edition of health IT certification criteria] compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.”

	==Next Steps==		==Next Steps==
	# Socialize the concepts with the Kantara Leadership		# Socialize the concepts with the Kantara Leadership

Tomjones: /* Disclaimer */

2020-11-10T23:07:17Z

Disclaimer

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	* from 42 CFR 170.523 (k)(1) (i)		* from 42 CFR 170.523 (k)(1) (i)
	“This Health IT Module is [specify Edition of health IT certification criteria] compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.”		“This Health IT Module is [specify Edition of health IT certification criteria] compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.”
			==Next Steps==
			# Socialize the concepts with the Kantara Leadership
			# Convert this into a proposal to the ONC
			# Send to ONC by 12/15

	==References==		==References==

Tomjones: /* Operational Requirements on the ACB */

2020-11-10T23:05:16Z

Operational Requirements on the ACB

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	===Operational Requirements on the ACB===		===Operational Requirements on the ACB===
	* The following are required of any [[Authorized Certification Body]].<blockquote>In the regulatory text, we removed § 170.523(k)(2) to further reduce administrative burden for health IT developers and ONC-ACBs, and included the instructions to do so (85 FR 25951). Because we removed § 170.523(k)(2), the requirement in § 170.523(f)(1)(xxi) that the ONC-ACB include the attestation from that section in its certified product listing should also have been removed. We inadvertently omitted that removal from the amendatory instructions for § 170.523(f) (85 FR 25950). We are correcting the error by removing the requirement in § 170.523(f)(1)(xxi) because the Principles of Proper Conduct for ONC-ACBs should accurately reflect the policies we proposed, the public commented on, and that we then finalized in the ONC Cures Act Final Rule. Further, because the remnant has no meaning in the absence of the other provision, and can impose no benefit or obligation, the correction of such errors does not constitute a substantive change. As such, we therefore find that there is good cause to waive the notice and comment procedures of the APA as unnecessary (5 U.S.C. § 553(b)(B)).</blockquote>		* The following are required of any [[Authorized Certification Body]].<blockquote>In the regulatory text, we removed § 170.523(k)(2) to further reduce administrative burden for health IT developers and ONC-ACBs, and included the instructions to do so (85 FR 25951). Because we removed § 170.523(k)(2), the requirement in § 170.523(f)(1)(xxi) that the ONC-ACB include the attestation from that section in its certified product listing should also have been removed. We inadvertently omitted that removal from the amendatory instructions for § 170.523(f) (85 FR 25950). We are correcting the error by removing the requirement in § 170.523(f)(1)(xxi) because the Principles of Proper Conduct for ONC-ACBs should accurately reflect the policies we proposed, the public commented on, and that we then finalized in the ONC Cures Act Final Rule. Further, because the remnant has no meaning in the absence of the other provision, and can impose no benefit or obligation, the correction of such errors does not constitute a substantive change. As such, we therefore find that there is good cause to waive the notice and comment procedures of the APA as unnecessary (5 U.S.C. § 553(b)(B)).</blockquote>
			This section needs to be combined with data from the 5/1 Final Rule and turned into English.

	===Disclaimer===		===Disclaimer===