Senators Look to Change Federal Rules for Electronic Health Records

A bi­par­tis­an pair of sen­at­ors Tues­day in­tro­duced le­gis­la­tion aimed at im­prov­ing elec­tron­ic health re­cords’ trans­par­ency and ac­count­ab­il­ity.

Since the spring, Sen­ate Health, Edu­ca­tion, Labor, and Pen­sions Com­mit­tee mem­bers have been dis­sect­ing elec­tron­ic health re­cords, un­earth­ing a lit­any of prob­lems with this in­form­a­tion tech­no­logy. And in the middle of one such hear­ing, a bi­par­tis­an con­sensus emerged—one that turned in­to the bill in­tro­duced Tues­day.

As Sen. Shel­don White­house re­calls, he heard Sen. Bill Cas­sidy ask­ing tough ques­tions on gag or­ders bar­ring doc­tors and hos­pit­als from dis­cuss­ing spe­cif­ic glitches in their pur­chased sys­tems. “I said right across the hear­ing room, ‘If you’re look­ing for a co­spon­sor on that, let me know,’” White­house, a Rhode Is­land Demo­crat, told Na­tion­al Journ­al.”

So, the two HELP Com­mit­tee mem­bers teamed up and in­tro­duced the Trust IT Act of 2015 Tues­day. The meas­ure would es­tab­lish a health IT rat­ing sys­tem that lets con­sumers com­pare dif­fer­ent products; ban health IT vendors from hav­ing nondis­clos­ure clauses in con­tracts; re­quire products meet­ing cer­tain se­cur­ity and in­ter­op­er­ab­il­ity re­quire­ments for cer­ti­fic­a­tion; and more.

The bill comes at a time when the HELP Com­mit­tee has made im­prov­ing health in­form­a­tion tech­no­logy a pri­or­ity, and as Obama­care aims to bol­ster the ex­change of health in­form­a­tion through elec­tron­ic health re­cords. Also, the le­gis­la­tion’s in­tro­duc­tion came on the same af­ter­noon that the Health and Hu­man Ser­vices De­part­ment re­leased two fi­nal rules aimed at in­creas­ing in­ter­op­er­ab­il­ity and im­prov­ing pa­tient out­comes.

The com­mit­tee has been hold­ing a series of hear­ings on elec­tron­ic health re­cords since March as it eyes in­tro­du­cing a bi­par­tis­an med­ic­al-in­nov­a­tion bill by the end of this year, and ac­cord­ing to a Re­pub­lic­an HELP aide, Chair­man Lamar Al­ex­an­der ex­pects that much of the newly in­tro­duced bill from White­house and Cas­sidy could be in­cor­por­ated in­to the com­mit­tee’s in­nov­a­tion le­gis­la­tion.

In late April, Al­ex­an­der and the pan­el’s top Demo­crat, Sen. Patty Mur­ray, an­nounced a bi­par­tis­an, full-com­mit­tee work­ing group aimed at find­ing ways to im­prove elec­tron­ic health re­cords. Staff from both parties began meet­ing with health pro­fes­sion­als, health in­form­a­tion tech­no­logy de­velopers, and oth­er ex­perts in the field.

In the chair­man’s words at a June hear­ing, elec­tron­ic health IT is a “tech­no­logy that has great prom­ise, but through bad policy and bad in­cent­ives, it has run off track.”

After those re­marks at a hear­ing titled “Health In­form­a­tion Ex­change: A Path To­wards Im­prov­ing the Qual­ity and Value of Health Care for Pa­tients,” Mur­ray named sev­er­al itemsthat needed im­prov­ing: shar­ing in­form­a­tion between dif­fer­ent sys­tems, known as in­ter­op­er­ab­il­ity; in­creas­ing the ease of shop­ping for elec­tron­ic health re­cord sys­tems; en­sur­ing the se­cur­ity of pa­tients’ health in­form­a­tion; and more. The new le­gis­la­tion ad­dresses some of these is­sues, and in a state­ment to Na­tion­al Journ­al, Mur­ray said: “I truly ap­pre­ci­ate the bi­par­tis­an work Sen­at­ors White­house and Cas­sidy have done to­ward im­prov­ing our health care sys­tem through stronger health in­form­a­tion tech­no­logy. I look for­ward to re­view­ing the le­gis­la­tion and con­tinu­ing our ef­forts to­geth­er to ad­vance med­ic­al in­nov­a­tion for fam­il­ies.”

Part of the new bill deals with gag clauses; a Septem­berPolitico re­port de­tailed that some big firms mar­ket­ing elec­tron­ic re­cord sys­tems have con­tracts bar­ring pro­viders from talk­ing about the bugs in the sys­tems.

“If you have a product which just does not work, the pro­vider can’t tell any­body about that,” Cas­sidy, a Louisi­ana Re­pub­lic­an, told Na­tion­al Journ­al last week. “And so you have tax­pay­er-sub­sid­ized products ba­sic­ally—be­cause people are get­ting such heavy sub­sidies to pur­chase them—which don’t work, but no one can know it.”

The le­gis­la­tion would change this, re­quir­ing health vendors to at­test that they don’t par­ti­cip­ate in cer­tain in­form­a­tion-block­ing tac­tics and al­low­ing the HHS in­spect­or gen­er­al to in­vest­ig­ate such al­leg­a­tions and as­sess pen­al­ties for those en­ga­ging in such prac­tices.

An­oth­er key com­pon­ent of the bill is let­ting health care pro­viders com­pare products based on se­cur­ity, us­ab­il­ity, and in­ter­op­er­ab­il­ity. It would es­tab­lish a health IT rat­ing sys­tem that would be avail­able on­line at the Of­fice of the Na­tion­al Co­ordin­at­or for Health In­form­a­tion Tech­no­logy web­site.

“Right now, after a health IT product is cer­ti­fied for use, there’s no way to en­sure that it con­tin­ues to de­liv­er as prom­ised for doc­tors and pa­tients, and no way to eas­ily com­pare one product to an­oth­er,” White­house said in a press re­lease an­noun­cing the bill. “This bill will es­tab­lish im­port­ant safe­guards to pre­vent sys­tems from un­der­per­form­ing and will grade them on their per­form­ance—changes that will im­prove mar­ket com­pet­i­tion and drive in­nov­a­tion.”

An­oth­er pro­vi­sion of the bill would re­quire that, in or­der to be cer­ti­fied, health IT products would have to meet cer­tain se­cur­ity, in­ter­op­er­ab­il­ity, and user-friendly design re­quire­ments. The over­all goal is bet­ter co­ordin­a­tion, said Cas­sidy, who is a prac­ti­cing phys­i­cian, in the re­lease. “Doc­tors will be able to bet­ter care for their pa­tients and, in turn, de­liv­er on the prom­ise that their in­form­a­tion is be­ing used for their be­ne­fit and not for the be­ne­fit of oth­ers.”