Ensuring that your electronic health record product meets tightening federal certification requirements is getting more challenging as officials scrutinize health IT products more closely for hot-topic issues such as patient privacy, health information exchange and general transparency about their real-world capabilities.
Over the past several weeks, the Office of the National Coordinator for Health IT has been busy issuing proposed rules and publishing the names of non-complying vendors’ products. This flurry of activity has taken place in the several weeks leading up to ONC’s annual meeting in Washington DC.
A March 2nd proposal would give the ONC expanded authority to regulate health IT products under the certification program set up as part of the health IT incentive program known as HITECH. In response, a number of industry and health IT advocacy groups had responded that they were worried that the proposal was too far-reaching.
Late last month, ONC issued an updated list of health IT products and developers that have violated the Health IT certification program’s requirements. In making the announcement, ONC officials said they wanted to help purchasers of the products to “assess how products perform in real-world settings” and alert existing customers to potential issues with the software.
Among the products that no longer comply are EHRs like Practice Fusion and digital engagement platforms such as Allscripts FollowMyHealth, reported Healthcare Dive.
Developers whose products are found to be outside of the established standards under this ongoing surveillance program, ONC said, would have to submit a corrective action plan to fix the problem. The agency promised to update its list of products in violation of the requirements every week so vendors could quickly rehabilitate their products’ reputations. The announcement also clarified that just because a product is not in line with the standards does not mean the entire product is defective. At the same time, it said that if a product’s deficiencies are not addressed, it could be struck from the certified product list altogether.
Not long after, on June 1, ONC followed up with an announcement that it was enhancing transparency requirements for certified health IT products. “These new disclosures are designed to help purchasers and users better understand the capabilities and limitations of their health IT products,” ONC said. They are also meant to make vendors more accountable for their products, ONC said. Information about certification is meant to be easier to find on ONC’s redesigned Certified Health IT Product List and newly-launched transparency website.
In addition to making mandatory product disclosures, developers must also submit a transparency attestation that states whether they will take additional, voluntary actions to promote transparency. So far 566 vendors have made the transparency promise, Health Data Management reported, while 48 have declined.
Source: Health Data Management, June 2, 2016
ONC is serious about enforcing the new transparency requirements, saying that it will require ongoing surveillance of vendors and their products, and those that do not comply and fail to fix problems will have their certification terminated. The new rules are meant to give potential and current customers full information about the usability of their products, requiring IT developers to report all known costs and limitations a customer may encounter when using the technology. This information must be made available on developer websites and marketing materials in plain language.
“This is a way to put plain language information out there for providers who are looking to purchase health IT,” National Coordinator for HIT Karen DeSalvo said at the ONC meeting. “This is a way to really let folks know what they’re purchasing, know what they’re not and create a better platform for a transparent marketplace.”
To make it clear what ONC means by “plain language,” the agency will post a detailed listing on its website. The national standards for terminology would reduce confusion by ensuring everyone is on the same page, DeSalvo said.
The latest ONC moves are in response to widespread complaints by health IT users about problems they’ve had in everyday use of electronic health records, worries that have gained the ear of Congress, which is considering legislation to promote usability. Given that both lawmakers and regulators are putting greater pressure on developers to provide the marketplace with high-quality, usable products and to be transparent in how they market and implement them, it’s a good time for vendors to fully understand federal certification and transparency requirements.
Author: David Schoch
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