[{"innerBlocks":[],"name":"core\/freeform","postId":2952,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"The Office of the National Coordinator for Health Information Technology on Thursday announced two major changes to its Health IT Certification Program aimed at improving efficiency and reducing burdens on HIT developers and users.

Under its revisions to the program, ONC has approved developer self-declaration for more than 50 percent of test procedures and has exercised enforcement discretion for randomized surveillance of certified HIT products.

Developers will now self-declare their products\u2019 conformance to ONC-approved test procedures for 30 out of 55 certification criteria, so that they will not have to \u201cspend valuable time testing\u201d with an ONC-Authorized Testing Laboratory, according to the agency.

\u201cBy making this change, ONC enables ONC-ATLs and health IT developers to devote more of their resources and focus on the remaining interoperability-oriented criteria, aligning with the tenets of the 21st Century Cures Act,\u201d the agency\u2019 noted in its September 21 blog<\/a>. \u201cIn addition, health IT developers are still required to meet certification criteria requirements and maintain their products\u2019 conformance to the full scope of the criteria.\u201d

At the same time, the agency emphasized that \u201cany non-conformity complaints received and associated with these certification criteria would continue to be reviewed and investigated\u201d by ONC-Authorized Certification Bodies.

Also See<\/b>: ONC calls for shift to industry-developed testing tools<\/a>

When it comes to ONC-ACBs conducting randomized surveillance of certified HIT products, the agency said that it was exercising enforcement discretion and will not\u2014until further notice\u2014audit ONC-ACBs for compliance with randomized surveillance requirements or otherwise take administrative or other action to enforce such requirements.

\u201cThis exercise of enforcement discretion will permit ONC-ACBs to prioritize complaint-driven, or reactive, surveillance and allow them to devote their resources to certifying health IT to the 2015 Edition,\u201d according to the agency.

In a conference call, National Coordinator for HIT Donald Rucker, MD, said the changes to the certification program were made \u201cin the spirit of the administration\u2019s review of regulations and reductions.\u201d

Rucker noted that the agency\u2019s two revisions to the program will \u201creduce the vendor burden\u201d and \u201chopefully\u2014in part\u2014reduce the vendors\u2019 costs,\u201d which will ultimately trickle down to providers buying their products. He also said the changes will support greater availability of certified HIT for providers participating in the Centers for Medicare and Medicaid Services\u2019 new Quality Payment Program.

However, Karen DeSalvo, MD, former National Coordinator for HIT, was more tepid in her response to ONC\u2019s announcement.

\u201cThe certification is relatively young and, just as we did during my tenure as National Coordinator, should be subject to ongoing improvements and modifications,\u201d observed DeSalvo. \u201cThat said, our experience and feedback from stakeholders drove us to provide more oversight so we could better protect the safety of care and the financial investments of providers.\u201d

The ONC announcement comes just four months after eClinicalWorks, one of the nation\u2019s largest electronic health record vendors, agreed to pay $155 million as part of a settlement with the Department of Justice for allegedly misrepresenting the capabilities of its software\u2014a charge that has jolted provider confidence.

According to the DOJ allegation, eClinicalWorks falsely obtained certification for its EHR software when it concealed from its certifying entity that its software did not comply with requirements. Likewise, DOJ alleged that because providers used software that did not meet certification requirements, they unknowingly submitted false claims to the Medicare and Medicaid EHR Incentive Program.

The company has denied any wrongdoing. However, with ONC now making the majority of test procedures for health IT products subject to \u201cself-declaration\u201d by developers, it calls into question whether they can be counted on to be truthful about achieving certification for their software.

Nonetheless, Rucker downplayed these concerns. \u201cThe reality is these are very public products,\u201d he said. \u201cThey have user bases who immediately know if something is working or not working. Let\u2019s say, for example, with CPOE and an order didn\u2019t go through. These things are known almost instantaneously, so that the true bulk of the oversight is provided by the users using the product.\u201d

Rucker pointed out that in the case of DOJ\u2019s settlement with eClinicalWorks the allegation was based on user complaints about the software through complaint-driven, or reactive, surveillance. \u201cIt\u2019s what brought the eCW case to light,\u201d added an ONC official. In addition, they noted that self-declaration is not a new approach to certification and is used among other industry testing programs, and that the test procedures for HIT products now designated for self-declaration are for functionality-based certification criteria.

Not surprisingly, reactions from the health IT vendor community to ONC\u2019s revisions to the certification program were overwhelmingly upbeat, praising the agency actions.

\u201cThis a positive program change, especially if it forms the foundation of the future testing approach for ONC\u2019s program,\u201d said John Travis, vice president of regulatory and compliance strategy at Cerner. \u201cAnd, the measures taken to reduce burden in the surveillance program work to appropriately focus the oversight of the ONC-Authorized Certification Bodies to give priority to complaint-driven surveillance.\u201d

Likewise, Sasha TerMaat, chair of EHR Association and director at Epic Systems, expressed support for ONC\u2019s program changes.

\u201cWe have encouraged ONC to look for ways to make the certification process less expensive and more efficient,\u201d said TerMaat. \u201cWe therefore appreciate the direction and intent of the proposed changes, and look forward to reviewing the details of this new approach.\u201d

However, while Stephanie Zaremba, director of government and regulatory affairs at athenahealth, applauded the move, she contends that the agency did not go far enough in its changes.

\u201cWe\u2019re glad to see ONC taking a step to reduce the burden certification places on developers and providers, and look towards a broader reform of the certification program,\u201d said Zaremba. \u201cONC has an opportunity to go further by supporting and incenting business processes and technology that not only align with government programs, but foster and encourage innovation in service to patient and provider needs.\u201d","saveContent":"The Office of the National Coordinator for Health Information Technology on Thursday announced two major changes to its Health IT Certification Program aimed at improving efficiency and reducing burdens on HIT developers and users.

Under its revisions to the program, ONC has approved developer self-declaration for more than 50 percent of test procedures and has exercised enforcement discretion for randomized surveillance of certified HIT products.

Developers will now self-declare their products\u2019 conformance to ONC-approved test procedures for 30 out of 55 certification criteria, so that they will not have to \u201cspend valuable time testing\u201d with an ONC-Authorized Testing Laboratory, according to the agency.

\u201cBy making this change, ONC enables ONC-ATLs and health IT developers to devote more of their resources and focus on the remaining interoperability-oriented criteria, aligning with the tenets of the 21st Century Cures Act,\u201d the agency\u2019 noted in its September 21 blog<\/a>. \u201cIn addition, health IT developers are still required to meet certification criteria requirements and maintain their products\u2019 conformance to the full scope of the criteria.\u201d

At the same time, the agency emphasized that \u201cany non-conformity complaints received and associated with these certification criteria would continue to be reviewed and investigated\u201d by ONC-Authorized Certification Bodies.

Also See<\/b>: ONC calls for shift to industry-developed testing tools<\/a>

When it comes to ONC-ACBs conducting randomized surveillance of certified HIT products, the agency said that it was exercising enforcement discretion and will not\u2014until further notice\u2014audit ONC-ACBs for compliance with randomized surveillance requirements or otherwise take administrative or other action to enforce such requirements.

\u201cThis exercise of enforcement discretion will permit ONC-ACBs to prioritize complaint-driven, or reactive, surveillance and allow them to devote their resources to certifying health IT to the 2015 Edition,\u201d according to the agency.

In a conference call, National Coordinator for HIT Donald Rucker, MD, said the changes to the certification program were made \u201cin the spirit of the administration\u2019s review of regulations and reductions.\u201d

Rucker noted that the agency\u2019s two revisions to the program will \u201creduce the vendor burden\u201d and \u201chopefully\u2014in part\u2014reduce the vendors\u2019 costs,\u201d which will ultimately trickle down to providers buying their products. He also said the changes will support greater availability of certified HIT for providers participating in the Centers for Medicare and Medicaid Services\u2019 new Quality Payment Program.

However, Karen DeSalvo, MD, former National Coordinator for HIT, was more tepid in her response to ONC\u2019s announcement.

\u201cThe certification is relatively young and, just as we did during my tenure as National Coordinator, should be subject to ongoing improvements and modifications,\u201d observed DeSalvo. \u201cThat said, our experience and feedback from stakeholders drove us to provide more oversight so we could better protect the safety of care and the financial investments of providers.\u201d

The ONC announcement comes just four months after eClinicalWorks, one of the nation\u2019s largest electronic health record vendors, agreed to pay $155 million as part of a settlement with the Department of Justice for allegedly misrepresenting the capabilities of its software\u2014a charge that has jolted provider confidence.

According to the DOJ allegation, eClinicalWorks falsely obtained certification for its EHR software when it concealed from its certifying entity that its software did not comply with requirements. Likewise, DOJ alleged that because providers used software that did not meet certification requirements, they unknowingly submitted false claims to the Medicare and Medicaid EHR Incentive Program.

The company has denied any wrongdoing. However, with ONC now making the majority of test procedures for health IT products subject to \u201cself-declaration\u201d by developers, it calls into question whether they can be counted on to be truthful about achieving certification for their software.

Nonetheless, Rucker downplayed these concerns. \u201cThe reality is these are very public products,\u201d he said. \u201cThey have user bases who immediately know if something is working or not working. Let\u2019s say, for example, with CPOE and an order didn\u2019t go through. These things are known almost instantaneously, so that the true bulk of the oversight is provided by the users using the product.\u201d

Rucker pointed out that in the case of DOJ\u2019s settlement with eClinicalWorks the allegation was based on user complaints about the software through complaint-driven, or reactive, surveillance. \u201cIt\u2019s what brought the eCW case to light,\u201d added an ONC official. In addition, they noted that self-declaration is not a new approach to certification and is used among other industry testing programs, and that the test procedures for HIT products now designated for self-declaration are for functionality-based certification criteria.

Not surprisingly, reactions from the health IT vendor community to ONC\u2019s revisions to the certification program were overwhelmingly upbeat, praising the agency actions.

\u201cThis a positive program change, especially if it forms the foundation of the future testing approach for ONC\u2019s program,\u201d said John Travis, vice president of regulatory and compliance strategy at Cerner. \u201cAnd, the measures taken to reduce burden in the surveillance program work to appropriately focus the oversight of the ONC-Authorized Certification Bodies to give priority to complaint-driven surveillance.\u201d

Likewise, Sasha TerMaat, chair of EHR Association and director at Epic Systems, expressed support for ONC\u2019s program changes.

\u201cWe have encouraged ONC to look for ways to make the certification process less expensive and more efficient,\u201d said TerMaat. \u201cWe therefore appreciate the direction and intent of the proposed changes, and look forward to reviewing the details of this new approach.\u201d

However, while Stephanie Zaremba, director of government and regulatory affairs at athenahealth, applauded the move, she contends that the agency did not go far enough in its changes.

\u201cWe\u2019re glad to see ONC taking a step to reduce the burden certification places on developers and providers, and look towards a broader reform of the certification program,\u201d said Zaremba. \u201cONC has an opportunity to go further by supporting and incenting business processes and technology that not only align with government programs, but foster and encourage innovation in service to patient and provider needs.\u201d","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

Revisions to Health IT Certification Program get mixed reviews

More for you