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Medical Records: Laws and Standards
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Interoperability Standards (ONC Health IT Certification Program)
Requires that electronic health record systems meet certain standards for data sharing and interoperability; designed to allow for easier exchange and use of medical records across different health IT systems.
HIPAA (Health Insurance Portability and Accountability Act)
Protects the privacy of individually identifiable health information; sets boundaries on the use and release of health records; establishes safeguards that healthcare providers must achieve to protect the privacy of health information; holds violators accountable with civil and criminal penalties.
Family Educational Rights and Privacy Act (FERPA)
Governs access to educational information and records by public entities such as potential employers, publicly funded educational institutions, and foreign governments. It also applies to the health records of students maintained by educational institutions.
Confidentiality of Substance Use Disorder Patient Records (42 CFR Part 2)
Protects patient records created by federally assisted programs for the treatment of substance use disorders; sets forth stringent protections for patient records concerning the identity, diagnosis, prognosis, or treatment of any patient.
Patient Safety and Quality Improvement Act (PSQIA)
Encourages voluntary and confidential reporting of events that adversely affect patients; provides legal protections for providers who report patient safety issues.
CMS Meaningful Use Program
Incentivizes healthcare providers to use certified electronic health record technology in ways that can improve healthcare quality, efficiency, and patient safety; includes core objectives that providers must meet to qualify.
Affordable Care Act (ACA) - Health Care Data Reporting
Institutes various healthcare reforms; requires data collection and reporting to ensure health care quality and equitable treatment; includes reporting on disparities, which affects medical record keeping.
HITECH Act (Health Information Technology for Economic and Clinical Health Act)
Promotes the adoption and meaningful use of health information technology; strengthens the privacy and security protections for healthcare data under HIPAA; provides for breach notifications to patients.
Genetic Information Nondiscrimination Act (GINA)
Prohibits discrimination on the basis of genetic information with respect to health insurance and employment; protects the privacy of an individual's genetic information.
Mental Health Parity and Addiction Equity Act (MHPAEA)
Requires that the financial requirements (such as co-pays and deductibles) and treatment limitations (such as visit limits) applicable to mental health or substance use disorder benefits be no more restrictive than the predominant requirements or limitations applied to substantially all medical/surgical benefits.
Medicare Conditions of Participation
Specifies the quality and safety standards that hospitals and other providers must meet to participate in the Medicare and Medicaid programs; includes requirements for medical record services in these institutions.
Health Care Fraud Statute
Makes it a criminal offense to knowingly execute a scheme to defraud any healthcare benefit program; involves the need for accurate and truthful medical records to support billing practices.
21 CFR Part 11
Establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records; applies to pharmaceutical, clinical, and other FDA-regulated industries.
The Red Flag Rules
Requires certain healthcare entities to implement a written identity theft prevention program to detect the warning signs of identity theft in their day-to-day operations; affects medical record management to prevent fraud.
Emergency Medical Treatment and Labor Act (EMTALA)
Requires hospitals to provide emergency medical treatment to patients, regardless of their ability to pay, until they are stabilized; includes certain recordkeeping requirements related to emergency care and transfer.
The Joint Commission's Standards for Health Care Organizations
Sets performance standards for the quality and safety of patient care; accreditation by The Joint Commission can enhance reimbursement from payers and offers a competitive advantage in the healthcare market.
Food, Drug and Cosmetic Act
Provides the FDA the authority to oversee the safety of food, drugs, and cosmetics; regulates the labeling and handling of prescription medications, which includes maintaining certain patient records.
Medicare Access and CHIP Reauthorization Act (MACRA)
Establishes new ways to pay physicians for caring for Medicare beneficiaries; affects the way health records are used and reported, particularly concerning the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs).
ADA (Americans with Disabilities Act)
Prohibits discrimination against individuals with disabilities including in the realm of health services; establishes requirements for confidentiality of medical records for individuals with disabilities.
E-discovery in Litigation (Federal Rules of Civil Procedure)
Governs the process of discovering electronically stored information in litigation; affects how medical records are stored, retrieved, and produced in legal proceedings.
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