The 21st Century Cures Act (HR 6) is legislation authored by the U.S. House of Representatives Energy & Commerce Committee that seeks to better realize medical breakthroughs by accelerating and delivering innovation to patients. The legislation aims to achieve this by removing existing barriers that prohibit increased research and collaboration. The 21st Century Cures Act contains a number of provisions that are pertinent to the health IT community, specifically in the areas of FDA regulation, telehealth and interoperability.
FDA Regulation- Title II- Subtitle N- SEC. 2241. HEALTH SOFTWARE.
- Includes the Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act which amends the Federal Food, Drug, and Cosmetic Act to define and differentiate health software from health devices.
- Defines health software deemed to be "low risk," and removes the application of FDA regulation from "low risk" software.
- Grants discretion to regulate health software "intended for use to analyze information used to provide patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure or mitigation of a particular disease or condition" (e.g., clinical decision support) if the Secretary of HHS determines it poses a significant patient safety threat.
- Gives the Secretary of HHS authority to classify health accessories according to their intended use and independently of any classification of any parent device with which it is used.
Telehealth- Title III- Subtitle B- SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.
- Requires CMS to provide a report to Congress identifying the number of people dually eligible for Medicare and Medicaid services who would benefit from telehealth services, and the feasibility of implementing such services.
- Requires the Medicare Payment Advisory Commission (MEDPAC) to provide a report to Congress identifying telehealth services that can be paid for using both the fee-for-service and private insurance plans.
- Provides "Sense of Congress" language stating that eligible telehealth sites should be expanded, and that any expansions under the Medicare program recognize that telemedicine is a delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery.
Interoperability- Title III- Subtitle A - SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH INFORMATION TECHNOLOGY
- In order for health information technology to be considered interoperable, such technology must satisfy the following criteria: secure transfer, complete access to health information, and no information blocking. Also requires the individual transferring the information to still comply with HIPAA standards, including the "minimum necessary" requirement.
- Sets forth six categories of standards that are required for interoperability: vocabulary and terminology, content and structure, transport of information, security, service, querying and requesting health information for access, exchange, and use.
- Terminates the HIT Standards Committee and directs the Secretary of HHS to enter into contracts with health care standards development organizations (SDOs) accredited by the American National Standards Institute (or with ANSI who can subcontract with non-ANSI accredited organizations) to make recommendations on standards, corresponding implementation specifications, and methods to test whether health IT is compatible with standards and implementation specifications.
- Defines information blocking to include practices that the actor knows, or should know, prevent or materially discourage access to, exchange, or use of health information. Also provides exception and liability language.
- Noncompliance with interoperability standards and criteria by vendors of health information technology offered for use by a provider participating in Medicare or Medicaid, health information systems, hospitals, and other healthcare providers is punishable by decertification (of vendors) and civil monetary penalties (applied to vendors and providers).
- Aims to increase transparency by requiring vendors to report additional types of costs or fees associated with specific uses of health IT.
- Provides "Sense of Congress" language stating that interoperability is best achieved when individuals and authorized representatives have equal access to the health information in electronic format. Provides additional language stating that patients should have the right to access their information as well as have confidence in its accuracy.