MHDC is used to regulations from CMS and ONC affecting what we do. Even an occasional sprinkling of regulations from other agencies within HHS is normal. Right now, however, there is a veritable tsunami of proposed rules, RFIs, and other regulatory activity from all over the federal government impacting what MHDC does.
It’s coming at us full blast. Whether it’s proposed changes to race and ethnicity standards from the White House Office of Management and Budget (OMB), efforts to determine a national strategy for AI from the White House Office of Science and Technology Policy (OSTP), a new National Institute of Standards and Technology (NIST) framework for dealing with cybersecurity issues specific to genomic data, or proposed changes to the Federal Trade Commission (FTC) Health Data Breach Notification requirements, they all come from outside of HHS. Add in everything happening at the FDA, NIH, NCVHS, and AHRQ, let alone CMS and ONC, and it’s a lot.
MHDC is making a concerted effort to read, digest, discuss, and comment on this activity through our work with the Data Governance Collaborative or DGC. The rules are coming too frequently for us to address everything, especially when there are weeks with several regulatory deadlines. We've reluctantly had to skimp on comments, limit DGC discussion and review for some, and decide not to respond to others at all. Even so, we've submitted eight regulatory comments to six different agencies so far this year with several more comments currently in the works.
You can find all of our submitted regulatory comments and letters HERE and in future DGC updates. You can also learn about our thoughts on the currently pending ONC HTI-1 interoperability rule in this month's featured article. There may be a tsunami of regulation happening all around us, but MHDC is here to help you safely steer through it.
We are excited to be part of this challenging and rewarding transformation.
Missed an event? Click HERE for on-demand recordings!
Updates
The DGC has been busy addressing the tsunami of regulations coming our way. Since the last update, we have submitted four regulatory comments with varying levels of detail. We are also working on several more comments due in July or August and triaging new regulatory activity as it happens to prioritize what we bring to the DGC working group for discussion/what we comment on as a group.
As of June 21, most Point32Health systems are back online, including the member, employer, and broker portals as well as enrollment, claims, and billing systems. All Harvard Pilgrim Health Care and Tufts Health Plan NEHEN transactions have returned to normal processing. There is a backlog of manual transaction processing to catch up on which will take some time. Current systems may reflect their mid-April statuses until this is complete.
Welcome to the Dana Farber Cancer Institute, our newest Spotlight customer! Spotlight provides analyses of market share, patient origin, disease prevalence, cost of care, and comparative costs and outcomes for every acute care hospital in Massachusetts and Rhode Island. Plus, with the Lown Institute data, Spotlight also provides data on how Massachusetts providers rank and compare to each other in health equity, clinical outcomes, and value of care.
The ONC Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing proposed rule (HTI-1 for short) is a bit of a mishmash covering all sorts of proposals in a variety of areas:
updates to the data standards required for various certifications
various adjustments to API and other rules
mechanisms for patients to request specific data not be exchanged
interoperability quality measures reporting under a new Insights Conditions program
changes to the information blocking rules
changes to the way clinical decision support (now called decision support intervention) is managed and expands it to include AI and machine learning
The regulatory timeline chart has a new home. Click HERE
Industry Events
Interested in what's happening with health data, health IT, health equity, patient engagement, regulatory impact, etc.? Check out these upcoming online events:
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