[{"innerBlocks":[],"name":"core\/freeform","postId":185,"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":"As Congress looks to draft follow-up legislation to the 21st Century Cures Act, industry groups want to see lawmakers institute wide-ranging reforms to advance digital health and biomedical research. Responding to a public request from Reps. <\/b>Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) for stakeholder input, these associations contend that barriers remain to the widespread and effective use of health information technology\u2014challenges that \u201cCures 2.0\u201d must address.The 21st Century Cures Act, signed into law by President Barack Obama in December 2016, was meant to ensure greater patient access to healthcare records\u2014and the sharing of such information\u2014as well as to accelerate the development of medical innovations and breakthroughs.The Cures Act included several health IT interoperability provisions. Among them was a mandate from Congress to empower patients with open application programming interfaces (API) \u201cwithout special effort\u201d to assist with the access and exchange of health information.While the College of Healthcare Information Management Executives\u2019 letter<\/a> to DeGette and Upton voiced CHIME support for improving information sharing and patient care through use of APIs, at the same time the group said it is \u201cimperative that policies be put in place to prevent inappropriate disclosures of patient data to third-parties and resultant harm.\u201d Similarly, the Medical Group Management Association said it supports the use of APIs to enhance interoperability and give patients access to their health information. However, MGMA\u2019s letter<\/a> to DeGette and Upton laid out the group\u2019s concerns about the security implications with the deployment of APIs.\u201cAbsent appropriate privacy protections, we believe patient information is at risk of being sold, used for vendor marketing and shared without permission with third parties,\u201d wrote Anders Gilberg, senior vice president for government affairs at MGMA. Likewise, the American Medical Informatics Association called for updating privacy policies in light of \u201creal and significant\u201d privacy risks and opportunities for fraud\u2014outside the HIPAA-regulated environment\u2014as patients increasingly gain access to their health data via APIs. \u201cThe challenges posed to privacy, fraud and abuse in the near-term API-driven future will require that Congress acts to fill the consumer protection gaps residing just beyond the reach of HIPAA\u2014either now, as part of ongoing consumer data protection legislation discussions or at some point after more demonstrable harm is committed against Medicare and Medicaid beneficiaries and other patients who erroneously believe that their data is protected from misuse,\u201d according to AMIA.\u201c<\/b>Major technology companies and major retail stores are investing heavily in digital health tools and are working to leverage new troves of data to better understand patients\u2019 picture of health,\u201d <\/b>AMIA president and CEO Doug Fridsma, MD, wrote in a letter<\/a> to DeGette and Upton.Fridsma warned the members of Congress that \u201cthis blurring of clinical and consumer technologies brings both promise and opportunity for improving Americans\u2019 health and wellness, as well as increases risks to privacy and safety.\u201dIn particular, Fridsma expressed his concerns about a \u201clack of consumer protection for health data beyond the HIPAA-regulated environment\u201d and a \u201clack of evidentiary standards for digital health tools and mobile applications.\u201dIt\u2019s a sentiment shared by the American Health Information Management Association. In a letter<\/a> to DeGette and Upton, AHIMA CEO Wylecia Wiggs Harris voiced similar concerns about the existing regulatory landscape, which \u201clacks sufficient privacy and security guardrails to protect health information held by entities not covered by HIPAA.\u201d AHIMA\u2019s letter points out that there are many health-related technologies that exist and operate outside of the scope of HIPAA. \u201cWhile these health-related technologies produce and manage individually identifiable health information, they are not bound by or required to abide by the rules established under HIPAA because they are not considered covered entities\u2019 or \u2018business associates.\u2019 \u201dCHIME President and CEO Russ Branzell emphasized his group\u2019s strong support of patient access to their medical data, but expressed his members\u2019 concerns that \u201cpatients are unaware of how their data is being used once it is released and, in some cases, may be under the false impression that it is still safeguarded under HIPAA.\u201dOverall, AMIA\u2019s Fridsma urged Congress to \u201cthink centrally about how to ensure safety in our fast-approaching future dominated by innovations in artificial intelligence, big data aggregation, and advances in biotechnology.\u201dSpecifically, Fridsma made the following policy recommendations for congressional drafting of Cures 2.0:
Establish consumer protections for health data privacy.<\/li><\/ul>
Break down data silos funded by the National Institutes of Health. <\/li><\/ul>
Modernize regulation of software that performs medical device functions. <\/li><\/ul>
Focus on health data standards research & development. <\/li><\/ul>
Enable innovation and research within HIPAA-protected environments.<\/li><\/ul>
Improve patient safety and security with unique patient identifiers.<\/li><\/ul> Regarding the latter, <\/b>AHIMA similarly asked that Congress \u201cconsider legislative solutions to address the challenge of patient identification to ensure that patients are accurately identified and matched to their health information.\u201dCHIME\u2019s Branzell charged that \u201cwithout a standard patient identification solution, the creation of a longitudinal care record is simply not feasible.\u201d As a result, CHIME encouraged DeGette and Upton to examine the issue of patient ID and consider legislative solutions to ensure patients are accurately identified and matched to their data, including a \u201cdiscussion of expansion of the Medicare Beneficiary Identifier (MBI) created through MACRA, beyond the Medicare population.\u201dFor its part, MGMA proposed that the Centers for Medicare and Medicaid Services \u201cshould be required to work with appropriate industry stakeholders in addressing the issue of the accurate and appropriate matching of patient records.\u201d In addition, to improve patient matching, the group recommended that the Office of the National Coordinator for Health IT \u201csupport the standardization of demographic data, including applying the U.S. Postal Service Standard to the address field\u201d as well as \u201cencourage exploring the use of email address as an additional patient matching element.\u201dIn compliance with the Cures Act, ONC developed a proposed rule to advance interoperability\u2014among other provisions\u2014and to support the access, exchange and use of electronic healthcare information. In September, ONC\u2019s proposed rule was sent to the Office of Management and Budget for OMB\u2019s review. ONC is expected to release its final regulations in early 2020.\u201cThe Cures Act is vast, and the provisions established in Section 4000, for example, have not yet been finalized, nearly three years after passage,\u201d wrote Fridsma to DeGette and Upton. \u201cAs part of the fact-finding for Cures 2.0, AMIA encourages your offices to identify what key provisions are still in development and better understand how Cures 1.0 is being implemented.\u201d","saveContent":"As Congress looks to draft follow-up legislation to the 21st Century Cures Act, industry groups want to see lawmakers institute wide-ranging reforms to advance digital health and biomedical research. Responding to a public request from Reps. <\/b>Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) for stakeholder input, these associations contend that barriers remain to the widespread and effective use of health information technology\u2014challenges that \u201cCures 2.0\u201d must address.The 21st Century Cures Act, signed into law by President Barack Obama in December 2016, was meant to ensure greater patient access to healthcare records\u2014and the sharing of such information\u2014as well as to accelerate the development of medical innovations and breakthroughs.The Cures Act included several health IT interoperability provisions. Among them was a mandate from Congress to empower patients with open application programming interfaces (API) \u201cwithout special effort\u201d to assist with the access and exchange of health information.While the College of Healthcare Information Management Executives\u2019 letter<\/a> to DeGette and Upton voiced CHIME support for improving information sharing and patient care through use of APIs, at the same time the group said it is \u201cimperative that policies be put in place to prevent inappropriate disclosures of patient data to third-parties and resultant harm.\u201d Similarly, the Medical Group Management Association said it supports the use of APIs to enhance interoperability and give patients access to their health information. However, MGMA\u2019s letter<\/a> to DeGette and Upton laid out the group\u2019s concerns about the security implications with the deployment of APIs.\u201cAbsent appropriate privacy protections, we believe patient information is at risk of being sold, used for vendor marketing and shared without permission with third parties,\u201d wrote Anders Gilberg, senior vice president for government affairs at MGMA. Likewise, the American Medical Informatics Association called for updating privacy policies in light of \u201creal and significant\u201d privacy risks and opportunities for fraud\u2014outside the HIPAA-regulated environment\u2014as patients increasingly gain access to their health data via APIs. \u201cThe challenges posed to privacy, fraud and abuse in the near-term API-driven future will require that Congress acts to fill the consumer protection gaps residing just beyond the reach of HIPAA\u2014either now, as part of ongoing consumer data protection legislation discussions or at some point after more demonstrable harm is committed against Medicare and Medicaid beneficiaries and other patients who erroneously believe that their data is protected from misuse,\u201d according to AMIA.\u201c<\/b>Major technology companies and major retail stores are investing heavily in digital health tools and are working to leverage new troves of data to better understand patients\u2019 picture of health,\u201d <\/b>AMIA president and CEO Doug Fridsma, MD, wrote in a letter<\/a> to DeGette and Upton.Fridsma warned the members of Congress that \u201cthis blurring of clinical and consumer technologies brings both promise and opportunity for improving Americans\u2019 health and wellness, as well as increases risks to privacy and safety.\u201dIn particular, Fridsma expressed his concerns about a \u201clack of consumer protection for health data beyond the HIPAA-regulated environment\u201d and a \u201clack of evidentiary standards for digital health tools and mobile applications.\u201dIt\u2019s a sentiment shared by the American Health Information Management Association. In a letter<\/a> to DeGette and Upton, AHIMA CEO Wylecia Wiggs Harris voiced similar concerns about the existing regulatory landscape, which \u201clacks sufficient privacy and security guardrails to protect health information held by entities not covered by HIPAA.\u201d AHIMA\u2019s letter points out that there are many health-related technologies that exist and operate outside of the scope of HIPAA. \u201cWhile these health-related technologies produce and manage individually identifiable health information, they are not bound by or required to abide by the rules established under HIPAA because they are not considered covered entities\u2019 or \u2018business associates.\u2019 \u201dCHIME President and CEO Russ Branzell emphasized his group\u2019s strong support of patient access to their medical data, but expressed his members\u2019 concerns that \u201cpatients are unaware of how their data is being used once it is released and, in some cases, may be under the false impression that it is still safeguarded under HIPAA.\u201dOverall, AMIA\u2019s Fridsma urged Congress to \u201cthink centrally about how to ensure safety in our fast-approaching future dominated by innovations in artificial intelligence, big data aggregation, and advances in biotechnology.\u201dSpecifically, Fridsma made the following policy recommendations for congressional drafting of Cures 2.0:
Establish consumer protections for health data privacy.<\/li><\/ul>
Break down data silos funded by the National Institutes of Health. <\/li><\/ul>
Modernize regulation of software that performs medical device functions. <\/li><\/ul>
Focus on health data standards research & development. <\/li><\/ul>
Enable innovation and research within HIPAA-protected environments.<\/li><\/ul>
Improve patient safety and security with unique patient identifiers.<\/li><\/ul> Regarding the latter, <\/b>AHIMA similarly asked that Congress \u201cconsider legislative solutions to address the challenge of patient identification to ensure that patients are accurately identified and matched to their health information.\u201dCHIME\u2019s Branzell charged that \u201cwithout a standard patient identification solution, the creation of a longitudinal care record is simply not feasible.\u201d As a result, CHIME encouraged DeGette and Upton to examine the issue of patient ID and consider legislative solutions to ensure patients are accurately identified and matched to their data, including a \u201cdiscussion of expansion of the Medicare Beneficiary Identifier (MBI) created through MACRA, beyond the Medicare population.\u201dFor its part, MGMA proposed that the Centers for Medicare and Medicaid Services \u201cshould be required to work with appropriate industry stakeholders in addressing the issue of the accurate and appropriate matching of patient records.\u201d In addition, to improve patient matching, the group recommended that the Office of the National Coordinator for Health IT \u201csupport the standardization of demographic data, including applying the U.S. Postal Service Standard to the address field\u201d as well as \u201cencourage exploring the use of email address as an additional patient matching element.\u201dIn compliance with the Cures Act, ONC developed a proposed rule to advance interoperability\u2014among other provisions\u2014and to support the access, exchange and use of electronic healthcare information. In September, ONC\u2019s proposed rule was sent to the Office of Management and Budget for OMB\u2019s review. ONC is expected to release its final regulations in early 2020.\u201cThe Cures Act is vast, and the provisions established in Section 4000, for example, have not yet been finalized, nearly three years after passage,\u201d wrote Fridsma to DeGette and Upton. \u201cAs part of the fact-finding for Cures 2.0, AMIA encourages your offices to identify what key provisions are still in development and better understand how Cures 1.0 is being implemented.\u201d","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

Groups contend ‘Cures Act 2.0’ must address HIT challenges

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