The European Data Protection Board and a number of data protection authorities in EU Member States have issued guidance on how to safeguard EU/US data transfers post-Schrems II.
Click here to read the full article in our latest International News.
The Office of the National Coordinator for Health Information Technology recently released a report (the Report) detailing user experience research on patient access to health data. The Report sought to examine the experiences of 17 individuals and processes of 50 health systems, with commentary from four medical record fulfillment administrators, to determine how the medical record request process can be improved for consumers. The Report ultimately concludes that patients and health care providers alike are in need of a well-defined process that is convenient, expedient and transparent.
Background
The Health Insurance Patient Portability and Accountability Act (HIPAA) does not create a uniform process for storage and production of medical records across providers, and in-turn did not create a convenient request process for patients. Generally, patients have a right to access a designated record set, which includes 1) medical records and billing records about individuals maintained by or for a covered health care provider; 2) enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; and 3) other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals. Upon receipt of a request by a patient to access their health records, the covered entity receiving the request must produce the records within 30 days. Prior to producing those records, however, the covered entity must verify the identity of the individual making the request. This often involves signature verification or similar processes.
Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter. (Add this post to the noise!) While some may decry the comparison, there is a lot we can learn from that perspective.
One of the challenges of broad digital health adoption is the simple fact that digital health encompasses such a broad array of technologies, usages and purposes. There is no one tonic that will cure a list of ailments; rather we are presented with shelves of solutions to even more shelves of challenges waiting to be addressed. Digital health includes, by my definition, the application of social media tools to preventative health and chronic disease management measures, as well as highly sophisticated data analytics applied to massive amounts of population health data to identify important health trends. It also includes home monitoring devices that keep health care providers informed of their patient’s at-home health condition, as well as telestroke programs that allow physicians to access needed expertise. The list is potentially endless, as new technologies created to address health issues and existing technologies are being put to use in the health care context. (more…)
On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide Interoperability Roadmap and requested comments. The Roadmap seeks to lay out a framework for developing and implementing interoperable health information systems that will allow for the freer flow of health-related data by and among providers and patients. The use of technology to capture and understand health-related information and the strategic sharing of information between health industry stakeholders and its use is widely recognized as critical to support patient engagement, improve quality outcomes and lower health care costs.
On April 3, 2015, the Federal Trade Commission issued coordinated comments from its Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection and Bureau of Economics. The FTC has a broad, dual mission to protect consumers and promote competition, in part, by preventing business practices that are anticompetitive or deceptive or unfair to consumers. This includes business practices that relate to consumer privacy and data security. Notably, the FTC’s comments on the Roadmap draw from both its pro-competitive experience and its privacy and security protection perspective, and therefore offer insights into the FTC’s assessment of interoperability from a variety of consumer protection vantage points.
The FTC agreed that ONC’s Roadmap has the potential to benefit both patients and providers by “facilitating innovation and fostering competition in health IT and health care services markets” – lowering health care costs, improving population health management and empowering consumers through easier access to their personal information. The concepts advanced in the Roadmap, however, if not carefully implemented, can also have a negative effect on competition for health care technology services. The FTC comments are intended to guide ONC’s implementation with respect to: (1) creating a business and regulatory environment that encourages interoperability, (2) shared governance mechanisms that enable interoperability, and (3) advancing technical standards.
Taking each of these aspects in turn, creating a business and regulatory environment that encourages interoperability is important because, if left unattended, the marketplace may be resistant to interoperability. For example, health care providers may resist interoperability because it would make switching providers easier and IT vendors may see interoperability as a threat to customer-allegiance. The FTC suggests that the federal government, as a major payer, work to align economic incentives to create greater demand among providers for interoperability.
With respect to shared governance mechanisms, the FTC notes that coordinated efforts among competitors may have the effect of suppressing competition. The FTC identifies several examples of anticompetitive conduct in standard setting efforts for ONC’s consideration as it considers how to implement the Roadmap.
Finally, in advancing core technical standards, the FTC advised ONC to consider how standardization could affect competition by (1) limiting competition between technologies, (2) facilitating customer lock-in, (3) reducing competition between standards, and (4) impacting the method for selecting standards.
As part of its mission to protect consumers, the FTC focuses its privacy and security [...]
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