Establishment of the permanent certification program for health information technology. Final rule

This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent certification program could also be expanded to include the certification of other types of HIT.     

Data breaches. Interim final rule

This document establishes regulations to address data breaches regarding sensitive personal information that is processed or maintained by the Department of Veterans Affairs (VA). The regulations implement certain provisions of Title IX of the Veterans Benefits, Health Care, and Information Technology Act of 2006, which require promulgation of these regulations as an interim final rule.     

Data breaches. Final rule

This document adopts, without change, the interim final rule that was published in the Federal Register on June 22, 2007, addressing data breaches of sensitive personal information that is processed or maintained by the Department of Veterans Affairs (VA). This final rule implements certain provisions of the Veterans Benefits, Health Care, and Information Technology Act of 2006. The regulations prescribe the mechanisms for taking action in response to a data breach of sensitive personal information.     

National Practitioner Data Bank for Adverse Information on Physicians and other Health Care Practitioners: charge for self-queries. Health Resources and Services Administration, HHS. Final rule

This final rule amends the existing regulations implementing the Health Care Quality Improvement Act of 1986 (the Act), which established the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank). The final rule amends the existing fee structure so that the Data Bank can fully recover its costs, as required by law. This rule removes the prohibition against charging for self-queries and, therefore, allows the Data Bank to assess costs in an equitable manner. This is consistent with both the Freedom of Information Act and the Privacy Act which allow the Government to charge fees for the reproduction of records. The Data Bank will continue its current practice of sending to the practitioner in whose name it was submitted--automatically, without a request, and free of charge--a copy of every report received by the Data Bank for purposes of verification and dispute resolution.     

Tribal Self-Governance Amendments of 2000. Final rule

The Secretary of the Department of Health and Human Services (DHHS) hereby issues this final rule to implement Title V of the Tribal Self-Governance Amendments of 2000 (the Act). The final rule has been negotiated among representatives of Self-Governance and non-Self- Governance Tribes and the DHHS. The final rule includes provisions governing how DHHS/Indian Health Service (IHS) carries out its responsibility to Indian Tribes under the Act and how Indian Tribes carry out their responsibilities under the Act. As required by section 517 (b) of the Act, the Department has developed this final rule with active Tribal participation of Indian Tribes, inter-Tribal consortia, Tribal organizations and individual Tribal members, using the guidance of the Negotiated Rulemaking Act.     

Disclosure of information to organ procurement organizations. Interim final rule

This document amends the Department of Veterans Affairs (VA) regulations to implement section 204 of the Veterans Benefits, Health Care, and Information Technology Act of 2006. This regulatory change will provide authority for VA to provide individually-identifiable VA medical records of veterans or dependents of veterans who are deceased or whose death is imminent to representatives of organ procurement organizations (OPOs) as defined in section 371(b) of the Public Health Service Act (PHS Act), eye banks, and tissue banks to determine whether the patients are suitable potential donors.     

Availability of information to the public under the Freedom of Information Act; redelegation of authority--Office of the Secretary, HHS. Final regulation

The Department of Health and Human Services hereby amends its regulation implementing the Freedom of Information Act. This revision designates officials who shall have responsibilities for determining whether records must be withheld from disclosure, or released, under provisions of the Act (5 U.S.C. 552).     

Cyber pornography in India and its implication on cyber café operators

Cyber pornography plays an accessory role in negative social issues such as child abuse, violence against women, rape, inequality, relationship and family breakdown, youth crime, promiscuity and sexually transmitted diseases. Cyberspace and the pornographic matter transmitted through it have created challenges for India’s antiquated laws. The lack of jurisdictional boundaries and the sheer volume of traffic that the Internet can handle, as well as the potential for anonymity have resulted in a complete lack of control over what appears on the Web at the click of a mouse button. Before there was no liability of a cyber café owner but with the introduction of the Information Technology Amendment Act, 2008, the responsibilities of Cyber Café owners have only increased. This paper deals with the Cyber pornography, its legal implications and the liability of cyber café owner under the Information Technology Amendment Act, 2008.     

Administrative simplification: adoption of operating rules for eligibility for a health plan and health care claim status transactions. Interim final rule with comment period

Section 1104 of the Administrative Simplification provisions of the Patient Protection and Affordable Care Act (hereafter referred to as the Affordable Care Act) establishes new requirements for administrative transactions that will improve the utility of the existing HIPAA transactions and reduce administrative costs. Specifically, in section 1104(b)(2) of the Affordable Care Act, Congress required the adoption of operating rules for the health care industry and directed the Secretary of Health and Human Services to "adopt a single set of operating rules for each transaction * * * with the goal of creating as much uniformity in the implementation of the electronic standards as possible." This interim final rule with comment period adopts operating rules for two Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions: eligibility for a health plan and health care claim status. This rule also defines the term "operating rules" and explains the role of operating rules in relation to the adopted transaction standards. In general, transaction standards adopted under HIPAA enable electronic data interchange through a common interchange structure, thus minimizing the industry's reliance on multiple formats. Operating rules, in turn, attempt to define the rights and responsibilities of all parties, security requirements, transmission formats, response times, liabilities, exception processing, error resolution and more, in order to facilitate successful interoperability between data systems of different entities.     

The right of caregivers to access health information of relatives with mental illness

This article reviews the legal, ethical and practical challenges of complying with the Ontario Personal Health Information Protection Act (PHIPA) within the context of a Canadian mental health system that is overburdened and under resourced. The advent of deinstitutionalization has placed significantly increased responsibilities on the families of mentally ill individuals. While research evidences that involving family members in the care of their mentally ill relatives improves treatment outcomes, mental health practitioners constantly face the challenge of engaging family caregivers while also complying with privacy laws. The authors propose an Ontario Caregiver Recognition Act (OCRA) to formally recognize family caregivers as informal health information custodians based on the practice of other jurisdictions which incorporate the rights of family members actively engaged in providing care to their mentally ill relatives.     

Children's Health Insurance Program (CHIP); allotment methodology and States' fiscal years 2009 through 2015 CHIP allotments. Final rule

This final rule describes the implementation of funding provisions under Title XXI of the Social Security Act (the Act), for the Children's Health Insurance Program (CHIP), as amended by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), by other related CHIP legislation, and most recently by the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act). Specifically, this final rule addresses methodologies and procedures for determining States' fiscal years 2009 through 2015 allotments and payments in accordance with sections 2104 and 2105 of the Act, as amended by CHIPRA and the Affordable Care Act.     

Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.     

Student health insurance coverage. Final rule

This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines "student health insurance coverage" as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities--update. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule sets forth updates to the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year 2001. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act, as amended by the Medicare, Medicaid and State Child Health Insurance Program Balanced Budget Refinement Act of 1999, related to Medicare payments and consolidated billing for SNFs. In addition, this rule sets forth certain conforming revisions to the regulations that are necessary in order to implement amendments made to the Act by section 103 of the Medicare, Medicaid and State Child Health Insurance Program Balanced Budget Refinement Act of 1999.     

Indian Self-Determination and Education Assistance Act amendments--BIA, IHS. Notice of proposed rulemaking

The Secretaries of the Department of Interior (DOI) and the Department of Health and Human Services (DHHS) propose a joint rule to implement section 107 of the Indian Self-Determination Act, as amended, including Title I, Public Law 103-413, the Indian Self-Determination Contract Reform Act of 1994. A joint rule, as required by section 107(a)(2)(A)(ii) of the Act, will permit the Departments to award contracts and grants to Indian tribes without the unnecessary burden or confusion associated with having two sets of rules for single program legislation. In section 107(a)(1) of the Act Congress delegated to the Departments limited legislative rulemaking authority in certain specified subject matter areas, and the joint rule addresses only those specific areas. As required by section 107(d) of the Act, the Departments have developed this proposed rule with active tribal participation, using the guidance of the Negotiated Rulemaking Act.     

Release of information from Department of Veterans Affairs records--VA. Proposed rule

This document proposes to amend Department of Veterans Affairs (VA) regulations governing the confidentiality and release of VA records subject to the Privacy Act, the Freedom of Information Act (FOIA) (including the Electronic Freedom of Information Act Amendments of 1996), and the veterans' records confidentiality statute. The proposed rule sets forth a mechanism for the public to obtain information from the VA. The proposed rule is intended to maximize public availability of VA records to the extent permitted by law and considerations such a personal privacy or law enforcement. Essentially these provisions consist of restatements of statute, interpretations of statute, interpretations of case law, interpretations of Executive Orders, and clarification. The proposed amendments also would implement the Electronic Freedom of Information Act Amendments of 1996, court decisions and Executive Branch guidance issued since the regulations were originally published. Further, this document proposes to delegate authority to the Assistant General Counsel for Professional Staff Group IV for making final Departmental decisions on appeals under the Freedom of Information Act, the Privacy Act, and 38 U.S.C. 5701 and 5705. This would simplify decision making by allowing the highest level individual with direct responsibility for decision making to issue decisions.     

Public Health Service--Grants for graduate programs in health administration. Final rule

This rule sets forth requirements for Programs for Grants for Graduate Programs in Health Administration under section 791 of the Public Health Service Act (42 U.S.C. 295h), as amended by the Health Professions Educational Assistance Act of 1976 (Pub. L. 94-484).     

Medicaid program; modification of certain requirements for health insuring organizations--HCFA. Final rule

This final rule implements statutory changes which expressly made certain Health Insuring Organizations (HIOs) subject to Medicaid Health Maintenance Organization (HMO) rules. The statute implemented in this rule requires that an HIO which became operational on or after January 1, 1986, and arranges for comprehensive health services for Medicaid recipients on a risk basis be subject to HMO requirements. The statute also provides that exemptions from certain HMO rules are permitted for HIOs which began operation on or after January 1, 1986, if the HIOs are operating under a section 1915(b) waiver obtained prior to that date, or if an HIO is otherwise identified in the law. The exemptions continue as long as the waiver under section 1915(b) of the Social Security Act remains in effect. The statutory provisions implemented in this rule were enacted in section 9517(c) of the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended by section 9435(e) of the Omnibus Budget Reconciliation Act of 1986, and section 1895(c)(4) of the Tax Reform Act of 1986.     

Notice regarding the Federally Supported Health Centers Assistance Act of 1992--HRSA. Notice

On May 8, 1995, the Secretary of Health and Human Services published a final rule implementing certain provisions of the Federally Supported Health Centers Assistance Act of 1992 (the Act). The Act provides for liability protection for certain grantees of the Public Health Service and for certain individuals associated with these grantees. The Health Resources and Services Administration is the agency within the Department responsible for administering certain aspects of the Act. This notice provides further guidance regarding the final rule.