The House Energy and Commerce Committee has released an initial discussion document outlining proposals of its 21st Century Cures initiative to accelerate development and delivery of promising treatments, as well as streamline clinical trials and modernize medical product regulation.
The Republican-controlled committee announced that the 393-page document is a starting point in the legislative process to spur discussion and that it is seeking feedback on the proposals. The goal, lawmakers say, is to continue on an aggressive schedule to introduce 21st Century Cures legislation and ultimately send a bill to President Obamas desk for signature by the end of the year.
While provisions of the 21st Century Cures were authored by both Republicans and Democrats based on feedback from stakeholders over the past year, Rep. Frank Pallone, Jr. (D-N.J.), ranking member of the committee, issued a statement saying he was disappointed that the discussion document does not reflect true bipartisan collaboration. In its current form, I am concerned that the nearly 400 page draft could create more problems for our healthcare system than it solves, according to Pallone.
Among provisions included in the proposed legislation:
*Section 2181 includes placeholder language about working toward the goal of a national interoperable health information infrastructure.
*Section 2201 would require those receiving National Institutes of Health grants to share their data, subject to confidentiality and trade secret protections.
*Section 2221 would unlock the research potential of data siloed in healthcare facilities across the country and enable patients who want to play a more proactive role in finding better treatments or a cure for their disease to do so in a responsible manner that continues to protect their privacy.
*Section 4181 would advance opportunities for telemedicine and new technologies to improve the delivery of quality healthcare services to Medicare beneficiaries.
The draft bill also includes a new version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, which was first introduced by the committees vice chair Rep. Marsha Blackburn (R-Tenn.) in October 2013. The latest language of the SOFTWARE Act would curb the U.S. Food and Drug Administrations authority to regulate health information technology by establishing a risk-based regulatory framework for health IT that helps to provide regulatory certainty for those developing apps and health information technologies.
According to Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, the language in the new SOFTWARE Act bill is quite different from the previous version. The new legislation in many ways is much more simple and straightforward, Thompson tells Health Data Management. It creates a dividing line between software that FDA will regulate and software that should be unregulated. Overall, in my opinion, it's a huge step forward in the sense that it is much clearer and in some ways more focused than the earlier version.
In a written statement, Joe Ganley, vice president of federal government affairs at McKesson, said the company is pleased to see the inclusion of the updated SOFTWARE Act, which will increase efficiency and lower costs, two pillars of the 21st Century Cures Initiative.
Similarly, Joel White, executive director of the Health IT Now Coalition, said his organization applauds the release of the 21st Century Cures discussion document. Health IT Now is particularly pleased the committee is exploring solutions related to how health IT is regulated, interoperability, telehealth and electronic matching of patients to clinical trials. These are bipartisan and good solutions to our pressing health problems.
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