[{"innerBlocks":[],"name":"core\/freeform","postId":869,"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":"While the EHR Association supports the Office of the National Coordinator for Health IT\u2019s efforts to improve interoperability, the group contends that an ONC proposed rule exceeds the mandate of the 21st Century Cures Act and goes far beyond the intent of Congress.

\u201cWe worked throughout the drafting of the 21st Century Cures Act with Congress and are supportive of its goal to remove obstacles to information exchange, but we have found that the tremendously broad reach of the proposed rule goes far beyond Congressional intent,\u201d states EHRA in a blog posted this week. \u201cIn particular, we have significant concerns regarding timelines, ambiguous language, disincentives for innovation and definitions related to information blocking.\u201d

When it comes to the latter, EHRA notes that ONC\u2019s proposed rule seeks to implement the information blocking provisions of the Cures Act and includes seven exceptions to the definition of information blocking\u2014the act of intentionally interfering with the sharing of electronic health information.

However, the vendor group makes the case that the \u201cexceptions section as proposed do not seem enforceable\u201d and that ONC has \u201cgone well beyond what was intended, such as in the definitions of \u2018interoperability elements\u2019 and \u2018electronic health information\u2019 \u201d\u2014both of which EHRA says are \u201cwritten so broadly as to pull in technologies and stakeholders well outside of what is reasonable, and we strongly encourage that those definitions be revisited to narrow them significantly.\u201d

EHRA also takes exception to ONC\u2019s use of other \u201cambiguous language\u201d in the proposed rule, which it believes is problematic for \u201caffected stakeholders,\u201d who potentially face penalties of as much as $1 million per infraction.

\u201cWhile the language was well-crafted in many instances, some sections of the proposed rule offer room for interpretation, with words and phrases like \u2018reasonable\u2019 and \u2018as soon as possible,\u2019 \u201d according to the group. \u201cThese vagaries inherently conflict with ONC\u2019s intent to propagate a rule that is clear, predictable and administrable. For example, the phrase \u2018near real-time\u2019 requires clarification.\u201d

As a result, EHRA wants to see \u201cadditional clarifications and examples be made before finalization of the rule, possibly through issuance of an Interim Final Rule rather than a Final Rule this fall, to allow continuation of the clarification and feedback process.\u201d

The vendor group also charges that ONC\u2019s proposed rule, as written, \u201cwould discourage innovation by imposing limitations on profit as well as compulsory licensing terms for new intellectual property, created through extensive investment in development.\u201d

Specifically, EHRA complains that the proposed rule \u201crequires EHR developers and others to share their intellectual property with anyone who asks under Fair, Reasonable and Non-Discriminatory,\u201d or FRAND, terms.\u201d Under this compulsory licensing model, the group contends that \u201canyone could ask for our intellectual property, and for a \u2018reasonable\u2019 price-capped fee, they\u2019d be able to layer their own work over ours or otherwise repurpose it,\u201d which \u201cwould have a chilling effect on innovation, by removing incentives for new or <\/i>established companies to invest in emerging technologies or any significant effort to update existing ones.\u201d

EHRA also objects to the ONC\u2019s proposed rule for appearing to \u201cimply that established EHR developers are incapable of innovation,\u201d which it describes as \u201can inaccurate characterization that trivializes the work that companies in our association do every day to improve clinician experience and bring new emerging technologies to the market.\u201d

Earlier this year, ONC issued a proposed rule\u2014along with a companion rule from the Centers for Medicare and Medicaid Services\u2014intended to make electronic health information accessible to patients and providers. However, stakeholders have questioned whether the aims are achievable as the rules are currently written and within the proposed timelines.

Also See<\/b>: Industry voices concerns about proposed HHS interoperability rules<\/a>

For its part, EHRA contends that the ONC rule\u2019s \u201cproposed 24-month timeline for development, testing, training and implementation across all our clients is not feasible for the more challenging proposals, which require complex coding and implementation processes.\u201d

The vendor group comments that the \u201cshort timeframe also raises other questions, such as, how will potential conflicts between the timelines in the proposed rule and requirements of other CMS and ONC programs <\/b>be resolved?\u201d while noting that \u201cdevelopers and providers already juggle dozens of other regulations and reporting requirements, so it will be important to identify where and how measures in this proposal intersect with timeframes for existing rules or programs.\u201d

EHRA has yet to submit all of these comments on the proposed rule to ONC. Before making its submission to the agency, the group says the comments must still go through final rounds of review by EHRA\u2019s executive committee.","saveContent":"While the EHR Association supports the Office of the National Coordinator for Health IT\u2019s efforts to improve interoperability, the group contends that an ONC proposed rule exceeds the mandate of the 21st Century Cures Act and goes far beyond the intent of Congress.

\u201cWe worked throughout the drafting of the 21st Century Cures Act with Congress and are supportive of its goal to remove obstacles to information exchange, but we have found that the tremendously broad reach of the proposed rule goes far beyond Congressional intent,\u201d states EHRA in a blog posted this week. \u201cIn particular, we have significant concerns regarding timelines, ambiguous language, disincentives for innovation and definitions related to information blocking.\u201d

When it comes to the latter, EHRA notes that ONC\u2019s proposed rule seeks to implement the information blocking provisions of the Cures Act and includes seven exceptions to the definition of information blocking\u2014the act of intentionally interfering with the sharing of electronic health information.

However, the vendor group makes the case that the \u201cexceptions section as proposed do not seem enforceable\u201d and that ONC has \u201cgone well beyond what was intended, such as in the definitions of \u2018interoperability elements\u2019 and \u2018electronic health information\u2019 \u201d\u2014both of which EHRA says are \u201cwritten so broadly as to pull in technologies and stakeholders well outside of what is reasonable, and we strongly encourage that those definitions be revisited to narrow them significantly.\u201d

EHRA also takes exception to ONC\u2019s use of other \u201cambiguous language\u201d in the proposed rule, which it believes is problematic for \u201caffected stakeholders,\u201d who potentially face penalties of as much as $1 million per infraction.

\u201cWhile the language was well-crafted in many instances, some sections of the proposed rule offer room for interpretation, with words and phrases like \u2018reasonable\u2019 and \u2018as soon as possible,\u2019 \u201d according to the group. \u201cThese vagaries inherently conflict with ONC\u2019s intent to propagate a rule that is clear, predictable and administrable. For example, the phrase \u2018near real-time\u2019 requires clarification.\u201d

As a result, EHRA wants to see \u201cadditional clarifications and examples be made before finalization of the rule, possibly through issuance of an Interim Final Rule rather than a Final Rule this fall, to allow continuation of the clarification and feedback process.\u201d

The vendor group also charges that ONC\u2019s proposed rule, as written, \u201cwould discourage innovation by imposing limitations on profit as well as compulsory licensing terms for new intellectual property, created through extensive investment in development.\u201d

Specifically, EHRA complains that the proposed rule \u201crequires EHR developers and others to share their intellectual property with anyone who asks under Fair, Reasonable and Non-Discriminatory,\u201d or FRAND, terms.\u201d Under this compulsory licensing model, the group contends that \u201canyone could ask for our intellectual property, and for a \u2018reasonable\u2019 price-capped fee, they\u2019d be able to layer their own work over ours or otherwise repurpose it,\u201d which \u201cwould have a chilling effect on innovation, by removing incentives for new or <\/i>established companies to invest in emerging technologies or any significant effort to update existing ones.\u201d

EHRA also objects to the ONC\u2019s proposed rule for appearing to \u201cimply that established EHR developers are incapable of innovation,\u201d which it describes as \u201can inaccurate characterization that trivializes the work that companies in our association do every day to improve clinician experience and bring new emerging technologies to the market.\u201d

Earlier this year, ONC issued a proposed rule\u2014along with a companion rule from the Centers for Medicare and Medicaid Services\u2014intended to make electronic health information accessible to patients and providers. However, stakeholders have questioned whether the aims are achievable as the rules are currently written and within the proposed timelines.

Also See<\/b>: Industry voices concerns about proposed HHS interoperability rules<\/a>

For its part, EHRA contends that the ONC rule\u2019s \u201cproposed 24-month timeline for development, testing, training and implementation across all our clients is not feasible for the more challenging proposals, which require complex coding and implementation processes.\u201d

The vendor group comments that the \u201cshort timeframe also raises other questions, such as, how will potential conflicts between the timelines in the proposed rule and requirements of other CMS and ONC programs <\/b>be resolved?\u201d while noting that \u201cdevelopers and providers already juggle dozens of other regulations and reporting requirements, so it will be important to identify where and how measures in this proposal intersect with timeframes for existing rules or programs.\u201d

EHRA has yet to submit all of these comments on the proposed rule to ONC. Before making its submission to the agency, the group says the comments must still go through final rounds of review by EHRA\u2019s executive committee.","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

EHRA says ONC’s proposed interoperability rule needs major revisions

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