Health Data Sharing Bill Passes House in 344-70 Vote

In a 344-70 vote, the US House of Representatives passed a health data sharing bill that has been hotly debated by various healthcare organizations.

The 21st Century Cures bill is intended to overhaul drug development by giving researchers more access to certain health information. However, the increase in health data sharing, and proposed changes to HIPAA regulations, as caused concern to some organizations.

Earlier this month, the Minnesota-based Citizens Council for Health Freedom (CCHF) wrote a letter to McCarthy, members of the House, Speaker of the House John Boehner, and bill sponsor Rep. Fred Upton on why they should vote “no” on the bill.

“While a focus on rare diseases is mentioned, the bill does not limit it to such, creating the possibility of broad research on anyone with any ‘disease,’” CCHF said in its letter. “The requirement that the Secretary provide advice on ‘addressing associated patient privacy concerns’ is insufficient, as neither the bill nor HIPAA require informed written patient consent.”

However, a statement on the House Energy & Commerce Committee website explains that the legislation will help invest in science and medical innovation, incorporate the patient perspective, and modernize clinical trials, “to deliver better, faster cures to more patients and loved ones in need.”

The American Hospital Association (AHA) said in a recent letter that overall, it commends the House Energy & Commerce Committee’s efforts to accelerate medical care. Even so, AHA said that it is concerned with certain provisions aimed at ensuring interoperability of health IT.

“While we appreciate the positive changes made to the interoperability provisions and elsewhere in this legislation, the enforcement provisions in Section 3001 still rely on fraud and abuse mechanisms that will result in unfair sanctions to hospitals and other providers,” wrote AHA Executive Vice President Rick Pollack. “The bill also includes an overly broad definition of ‘information blocking’ that would result in penalties for providers’ reasonable business practices and beneficial modifications to information technology (IT) systems that improve patient care.”

The letter added that vendors and providers should therefore have different definitions of information blocking, and are as follows:

1. Limit or restrict electronic sharing, through certified EHRs, of patient information necessary for the care of the patient that is permissible to be shared under relevant federal and state privacy laws, insofar as the technology and supporting infrastructure have the capability to carry out such electronic sharing

2. Limit or restrict patients’ access to their electronic records, as specified in existing federal and state privacy laws, insofar as the provider has current capability to efficiently and effectively share the data electronically.

One of the larger concerns in terms of health data security is that the legislation states that researchers will not be prohibited in obtaining health information as long as certain circumstances are met. As long as appropriate security and privacy safeguards are maintained by the covered entity and the researcher and PHI is not copied or retained by the researcher, access could potentially be granted.

The 21st Century Cures Act moves onto the Senate this week.

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