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By James Swann
A top official expects a March or April release for a federal rule that will stop health-care data networks from blocking the sharing of electronic health-care data.
The Office of the National Coordinator for Health Information Technology is “laser-focused” on implementing several IT provisions required under the 21st Century Cures Act such as the information blocking rule, Kathryn Marchesini, the ONC’ s newly named chief privacy officer, told Bloomberg Law Jan. 12. Under Cures, the ONC is required to issue a rule defining what constitutes information blocking.
Information blocking can occur when a network vendor deliberately blocks or slows data exchange with a competing vendor, often charging a fee to share data. Defining information blocking will put health-care data networks on notice that their business practices may lead to penalties courtesy of the Health and Human Services Office of Inspector General.
Marchesini served as a senior health information technology and privacy adviser at the Health and Human Services Office for Civil Rights prior to being appointed to her new role, which she will assume Jan. 22.
The ONC is hard at work on another Cures provision, Marchesini said, referring to the Trusted Exchange Framework and Common Agreement (TEFCA). The framework includes a set of principles for effective health-data exchange among networks, covering everything from data transparency to standardization, and is the centerpiece of the ONC’s push to connect health-care networks and promote electronic data sharing.
The ONC released a draft of the Trusted Exchange Framework Jan. 5, and Marchesini said the final version would be available in late 2018.
“This is an inflection point on the road to interoperability,” Marchesini said, referring to the spate of upcoming ONC rules and noting that the health-care industry is finally ready to fully embrace electronic health-care data sharing.
Both the information-blocking rule and the TEFCA are critical to achieving one of the ONC’s main goals, health-data interoperability, Marchesini said. Interoperability refers to the seamless flow of electronic health-care data among data networks.
The large amount of available digital health-care data makes it essential to create a safe way to share data electronically, Marchesini said. The ONC role is to coordinate the transition to full interoperability, Marchesini said, not to take full control, and the agency will look to stakeholders to take a leading role in building out data sharing.
The ONC will seek to address privacy and security concerns over stakeholders accessing the available digital health-care data, Marchesini said.
Marchesini said the ONC would also continue its close coordination with the OCR on privacy and security issues.
The ONC made a good decision in reversing its earlier plan to eliminate the office of the chief privacy officer, W. Reece Hirsch, a health-care attorney with Morgan, Lewis & Bockius LLP in San Francisco, told Bloomberg Law Jan. 16.
“At this time when the health-care industry is being targeted by increasingly sophisticated cyberattacks, the ONC chief privacy officer plays a pivotal role in advising the National Coordinator for HIT on big-picture privacy and security issues,” Hirsch, a Bloomberg Law advisory board member, said.
Marchesini is likely to focus on building a consensus among health-care stakeholders on issues like achieving interoperability and reconciling the competing privacy interests related to clinical research,” Hirsch said.
“Deven McGraw did an outstanding job in her dual role at ONC and OCR, but Kathryn Marchesini looks to be a very well-qualified successor at ONC,” Hirsch said.
McGraw. the acting ONC chief privacy officer until she resigned in October 2017, also served as the deputy director for health information privacy at the OCR.
The ONC is likely to face two major privacy and security issues moving forward, including whether the push to streamline the rules for electronic health records will positively or negatively impact privacy and security, Kirk Nahra, a health-care attorney with Wiley Rein in Washington and Bloomberg Law advisory board member, said Jan. 16. Marchesini will presumably advocate for continued privacy and security controls but not expanded controls, Nahra said.
The second issue is determining what role the ONC will play in the privacy and security space beyond the specific role defined for the chief privacy officer, Nahra said.
“She’s got a tough job, because the push is really on to streamline,” Nahra said.
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The draft of the OCR's Trusted Exchange Framework is at https://www.healthit.gov/sites/default/files/draft-trusted-exchange-framework.pdf.
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