<img style="float: right;" src="https://opedge.com/Content/OldArticles/images/2002-10_10/Allen,-Mike-PE.jpg" hspace="4" vspace="4" /> On August 14, the Department of Health and Human Services (HHS) issued final modifications to the rule on medical privacy as required under the Health Insurance Portability and Accountability Act (HIPAA) to establish Standards for Privacy of Individually Identifiable Health Information (the Privacy Rules, or the Rules) which took effect on April 14, 2001. Many of the difficulties and administrative burdens created by the Privacy Rules will impact orthotic and prosthetic practitioners to a great extent; however, these final modifications do offer relief from some of the more onerous provisions contained in the previous Rule. Probably the most significant modification is that direct consent from patients will not be required to transfer their health information in "routine" health care activities. The Rules establish national standards for the protection of privacy interests in individuals' medical records and other personal health information. Generally, they afford patients increased access to and control over their records and health information, set boundaries on the use and disclosure of information, and require systems and procedures intended as safeguards to the privacy of health information. Violators of the Rules' requirements are subject to civil andin some circumstances, criminalpenalties for noncompliance. <h2>Summary of Final Modifications</h2> <b>Marketing</b> The final Rules require O&P practitioners to obtain an individual's prior written authorization to use his or her protected health information for marketing purposes, except for a face-to-face encounter or a communication involving a promotional gift of "nominal value." HHS defines marketing to distinguish between the types of communications that are and are not marketing, and makes clear that O&P practitioners are prohibited from selling lists of patients and enrollees to third parties or from disclosing protected health information to a third party for the marketing activities of the third party, without the individual's authorization. The Rules clarify that O&P practitioners communicating with patients about treatment options or the practitioners' own health-related products and services are not considered marketing. For example, health care plans can inform patients of additional health plan coverage and value-added items and services, such as discounts for medical supplies related to O&P. <b>Consent and Notice</b> In an attempt to change what some see as barriers to treatment, HHS made written consent by the patient optional for the transmittal of medical information for routine health care delivery purposes (known as treatment, payment, and health care operations). The Rules require O&P practitioners to provide patients with notice of the patient's privacy rights and the privacy practices of the O&P practice. The notice requires treatment providers to make a good-faith effort to obtain the patient's written acknowledgement of the notice of privacy rights and practices. This change is a major departure from the previous final Rules that established mandatory consent requirements. However, the Rules also allow consent requirements already in place to continue. <b>Uses and Disclosures Regarding Food and Drug Administration (FDA)-Regulated Products and Activities</b> The final Rules permit O&P practitioners to disclose protected health information without authorization to a person subject to the jurisdiction of the FDA for public health purposes related to the quality, safety, or effectiveness of FDA-regulated products or activities, such as collecting or reporting adverse events, dangerous products, and defects or problems with FDA-regulated products. <b>Incidental Use and Disclosure</b> The final Rules acknowledge that uses or disclosures that are incidental to an otherwise permitted use or disclosure may occur. Such incidental uses or disclosures are not considered a violation of the Rules, provided that the covered entity has met the reasonable safeguards and minimum necessary requirements. <b>Authorization</b> The final Rules clarify the authorization requirements of the Privacy Rules to eliminate separate authorization requirements for O&P practitioners. Patients will have to grant permission in advance for each type of non-routine use or disclosure, but providers will not have to use different types of forms. <h2>Political Reactions to Modified Final Rules</h2> The Bush administration, which drafted the Rules, and other supporters collectively agreed that the Rules strike just the right balance between protecting patients and the need to share some medical information. However, many privacy advocates stated their displeasure with the Rules, saying they "fall woefully short." Joanne Hustead, senior counsel to Georgetown University's Health Privacy Project, stated that the Rules "undermine patient control over private medical information" and "will erode patient trust in the health care system." And according to a spokesperson for Senator Edward Kennedy (D-MA), the senator will attempt to strengthen the rules after the August recess. <i>National Association for the Advancement of Orthotics and Prosthetics (NAAOP)</i>
<img style="float: right;" src="https://opedge.com/Content/OldArticles/images/2002-10_10/Allen,-Mike-PE.jpg" hspace="4" vspace="4" /> On August 14, the Department of Health and Human Services (HHS) issued final modifications to the rule on medical privacy as required under the Health Insurance Portability and Accountability Act (HIPAA) to establish Standards for Privacy of Individually Identifiable Health Information (the Privacy Rules, or the Rules) which took effect on April 14, 2001. Many of the difficulties and administrative burdens created by the Privacy Rules will impact orthotic and prosthetic practitioners to a great extent; however, these final modifications do offer relief from some of the more onerous provisions contained in the previous Rule. Probably the most significant modification is that direct consent from patients will not be required to transfer their health information in "routine" health care activities. The Rules establish national standards for the protection of privacy interests in individuals' medical records and other personal health information. Generally, they afford patients increased access to and control over their records and health information, set boundaries on the use and disclosure of information, and require systems and procedures intended as safeguards to the privacy of health information. Violators of the Rules' requirements are subject to civil andin some circumstances, criminalpenalties for noncompliance. <h2>Summary of Final Modifications</h2> <b>Marketing</b> The final Rules require O&P practitioners to obtain an individual's prior written authorization to use his or her protected health information for marketing purposes, except for a face-to-face encounter or a communication involving a promotional gift of "nominal value." HHS defines marketing to distinguish between the types of communications that are and are not marketing, and makes clear that O&P practitioners are prohibited from selling lists of patients and enrollees to third parties or from disclosing protected health information to a third party for the marketing activities of the third party, without the individual's authorization. The Rules clarify that O&P practitioners communicating with patients about treatment options or the practitioners' own health-related products and services are not considered marketing. For example, health care plans can inform patients of additional health plan coverage and value-added items and services, such as discounts for medical supplies related to O&P. <b>Consent and Notice</b> In an attempt to change what some see as barriers to treatment, HHS made written consent by the patient optional for the transmittal of medical information for routine health care delivery purposes (known as treatment, payment, and health care operations). The Rules require O&P practitioners to provide patients with notice of the patient's privacy rights and the privacy practices of the O&P practice. The notice requires treatment providers to make a good-faith effort to obtain the patient's written acknowledgement of the notice of privacy rights and practices. This change is a major departure from the previous final Rules that established mandatory consent requirements. However, the Rules also allow consent requirements already in place to continue. <b>Uses and Disclosures Regarding Food and Drug Administration (FDA)-Regulated Products and Activities</b> The final Rules permit O&P practitioners to disclose protected health information without authorization to a person subject to the jurisdiction of the FDA for public health purposes related to the quality, safety, or effectiveness of FDA-regulated products or activities, such as collecting or reporting adverse events, dangerous products, and defects or problems with FDA-regulated products. <b>Incidental Use and Disclosure</b> The final Rules acknowledge that uses or disclosures that are incidental to an otherwise permitted use or disclosure may occur. Such incidental uses or disclosures are not considered a violation of the Rules, provided that the covered entity has met the reasonable safeguards and minimum necessary requirements. <b>Authorization</b> The final Rules clarify the authorization requirements of the Privacy Rules to eliminate separate authorization requirements for O&P practitioners. Patients will have to grant permission in advance for each type of non-routine use or disclosure, but providers will not have to use different types of forms. <h2>Political Reactions to Modified Final Rules</h2> The Bush administration, which drafted the Rules, and other supporters collectively agreed that the Rules strike just the right balance between protecting patients and the need to share some medical information. However, many privacy advocates stated their displeasure with the Rules, saying they "fall woefully short." Joanne Hustead, senior counsel to Georgetown University's Health Privacy Project, stated that the Rules "undermine patient control over private medical information" and "will erode patient trust in the health care system." And according to a spokesperson for Senator Edward Kennedy (D-MA), the senator will attempt to strengthen the rules after the August recess. <i>National Association for the Advancement of Orthotics and Prosthetics (NAAOP)</i>