The 21st Century Cures Act, signed December 13, 2016 by President Obama, promotes and funds the acceleration of research into preventing and curing serious illnesses; accelerates drug and medical device development; attempts to address the opioid abuse crisis; and tries to improve mental health service delivery. The Act includes a number of provisions that push for greater interoperability, adoption of electronic health records (EHRs) and support for human services programs.
This bipartisan bill was passed by a Republican Congress and signed by a Democratic President. The law has been called the “most important bill of the year“ by Senate health committee Chairman Lamar Alexander (R-Tenn.).
While the bill is largely known to help fund efforts such as precision medicine, it contains some health IT-related provisions to improve healthcare IT- most notably, in relation to nationwide interoperability and information blocking. Certain sections are focused on "improving quality of care for patients", with interoperability a main concern. It also places strong emphasis on providing patients access to their electronic health information that is "easy to understand, secure and updated automatically."
Low-risk medical devices - The FDA is barred from regulating mobile health apps designed to maintain or encourage a healthy lifestyle if unrelated to the diagnosis, prevention, or treatment of disease. This law will help get more innovative, low-risk technology in patients’ hands.
Interoperability – The law envisions a continuing strong federal role by the ONC in the regulation and development of HIT standards. One way the bill takes aim to drive greater interoperability is by having ONC assist public-private partnerships to create a “trusted exchange framework, including a common agreement among health information networks nationally.” Overall, the legislation aims to promote interoperability among disparate EHRs. The bill also instructs ONC to work with the National Institute of Standards and Technology and other federal agencies to ensure "full network to network exchange of health information." ONC would also help set up a provider directory for those that have adopted the agreement and data exchange standards.
In addition, HHS will be tasked to “educate healthcare providers on ways of leveraging the capabilities of health information exchanges” and “clarify misunderstandings” on HIEs’ use.
Mental Health - Dr. John P. Docherty, senior vice president and medical director from ODH, Inc., tells the passage “of this bill in the House marks the first mental health reform bill in more than 50 years. It would require providers to care for the whole person, not just the physical.”
It also calls for revised understanding and clarification of HIPAA regarding permissible practices of communication. When patients suffer from drug addiction or mental health issues, the privacy rule “may hinder appropriate communication of health care information or treatment preferences with appropriate caregivers”.
HIPAA - The HHS Secretary will clarify HIPAA privacy rules defining when family members and caregivers can receive health information and notification of treatment options on behalf of the patient. Provisions in this section of the Act are specific to patients who are mentally or physically unable to make their own decisions. The law gives medical caregivers the ability, based on their judgement for the best possible outcome for the patient, to share PHI with other caregivers and family.
About the author: In her role at Conduent, Betty is responsible for MMIS system compliance against Federal and State rules and regulations. Betty currently serves on HIMSS Business Edge, is Co-Chair of X12 Provider Information and serves on various WEDI Work Groups.