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Patient Data Privacy, Protected Health Information, and Ethics of Real-World Evidence
Published in Kelly H. Zou, Lobna A. Salem, Amrit Ray, Real-World Evidence in a Patient-Centric Digital Era, 2023
Corinne S. Pillai, Eleanor E. Panico, Kelly H. Zou, Ewa Filipowska
To date, health authorities around the world are realizing the potential and application of RWE and are responding to this enthusiasm by issuing guidance to industry, which includes important considerations for ensuring ethical use of such information for the advancement of science. In the US, the FDA has developed a framework for an RWE program (Real-World Evidence, US FDA 2021, FDA in brief 2019, California Consumer Privacy Act). There are several guidance documents, including the “Use of Electronic Health Records in Clinical Investigations,” “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” “Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics, Developing Real-World Data and Evidence to Support Regulatory Decision-Making.” FDA has also announced a new Sentinel system contract, affirming its commitment to harnessing RWD to improve the safety and effectiveness of drugs. For data privacy protection, there is also the “California Consumer Privacy Act” (CCPA).
Healthcare Data Ownership and Privacy: A Perspective for Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Ximena Benavides, Greg Licholai
Some states have taken legislative initiatives themselves, following the European Union's General Data Protection Regulation (GDPR)25 in force since May 2018. First, California passed the Consumer Privacy Act of 2018 (CCPA) that came into force in January 2020.26 A new CCPA proposition called the California Privacy Right Act (CPRA)27 will go into force in 2023. In March 2021, the Virginia legislature passed the Consumer Data Protection Act,28 a CCPA inspired bill that will come into force in 2023. Finally, the state of Colorado passed the Colorado Privacy Act (ColoPA) concerning additional protection of data relating to personal privacy.29 Similarly, lawmakers in Washington State have unsuccessfully attempted to pass a comprehensive state privacy legislation twice and are working again toward a third one. These emerging state legislative initiatives might have complicated the prospects of setting a national standard and passing a federal data privacy law. To be sure, HIPAA does not preempt state laws that are more protective of privacy. The proliferation of state data privacy bills can also be a political incentive for federal lawmakers to enact a “new comprehensive HIPAA.” Overall, state legislative data privacy initiatives should be considered a non-governmental stopgap that prevents the urgently needed comprehensive federal government action.
An overview of the available treatments for chronic cavitary pulmonary aspergillosis
Published in Expert Review of Respiratory Medicine, 2020
Inderpaul Singh Sehgal, Sahajal Dhooria, Valliappan Muthu, Kuruswamy Thurai Prasad, Ritesh Agarwal
The CPA are an important yet under-recognized group of disorders. The umbrella term CPA includes SA at one end to SIA on the other. We believe that CPA should generally be restricted to CCPA and CFPA. This is because the treatment for SA is primarily surgery, and in SIA there is local tissue invasion that is not seen in CCPA or CFPA. The use of novel diagnostics such as lateral flow assay, or serum galactomannan (cutoff value, 0.6) followed by BALF galactomannan (cutoff value, 1.6) may improve detection rates within a structured protocol (Figure 3) [10,12], however this needs further prospective research and validation. Recently, a point-of-care lateral flow assay, has become available [94,95]. The test has shown promising results, like that of A.fumigatus-specific IgG. The lateral flow assay can be used in field settings and may prove especially of value in resource-constrained settings. In developing countries, patients with smear-negative pulmonary tuberculosis are frequently treated for tuberculosis despite lack of evidence [96]. In our opinion, many of these patients, may indeed be suffering from CPA. The point-of-care test may be of great value in differentiating TB from CPA in a health program setting.