The 21st Century Cures Act was signed into law on December 2016. The bill has several provisions, which includes increasing cancer research advancing research into the human brain through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) supporting the access to the medicine of all people through the Precision Medicine Initiative (PMI) and laying down financial sources for supporting mental health. The regulation also has several provisions that target health informatics such as encouraging interoperability of EHRs and allowing patients to have access to data and discouraging the blocking of health information (Congress.gov, 2016).
According to section 3060 of the 21 st Century Cures Act, it has substantially changed the regulation of software functions within the healthcare field. According to this new regulation, it classifies software basing on its functions rather than the platform. Through this, it is an indication that a mobile app and web site that have similar functions will be regulated similarly. The regulation has removed a couple of software outside the scope of a medical device definition. However, some devices will still be regulated as medical devices. This is an indication that during the implementation of various systems, healthcare practitioners will have to ensure they adhere to the new rules under section 3060 (U.S Food and Drug Administration, 2017).
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The act calls for interoperability in health care an indication that information required to coordinate care should easily be accessed without difficulties (Lye et al., 2018). This is an indication that there will be an improvement in health care delivery. Additionally, the act calls for smooth patient access to health data, which is bound to improve the patient-provider relationship. However, the act has increased the workflow processes, as the providers will have to ensure the EHRs support interoperability. Moreover, the act introduces EHR reporting program whereby providers’ must report the systems interoperability status, user-centered design, security and adherence to certification. Failure to meet these will see a provider facing a $1 million fine.
To ensure the regulation is addressed, training of all staff is inevitable (Rafiei & Davari, 2015). This will ensure all staff has access to adequate information and instructions related to the regulation. The regulation’s requirements will also be discussed regularly with staff during team meetings to make sure the staff has an awareness of the importance of the regulation.
References
Congress.gov (2016, December 13). 21 st Century Cures Act . Retrieved on 11 May 2019, from https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
Lye, C. T., Forman, H. P., Daniel, J. G., & Krumholz, H. M. (2018). The 21st Century Cures Act and electronic health records one year later: will patients see the benefits? Journal of the American Medical Informatics Association , 25 (9), 1218-1220.
Rafiei, N., & Davari, F. (2015). The Role of Human Resources Management on Enhancing the Teaching Skills of Faculty Members. Materia Socio-Medica , 27 (1), 35.
U.S Food and Drug Administration. (2017, December). Changes to existing medical software policies resulting from Section 3060 of the 21st Century Cures Act . Retrieved on 11 May 2019, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act
