Poten&al Impact of FDA Regula&on of EMRs. October 27, 2010

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1 Poten&al Impact of FDA Regula&on of EMRs October 27, 2010

2 Agenda The case for regula&ng Impact on manufacturers Impact on providers Recommenda&ons and best prac&ces 2

3 A Medical Device Is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related ar&cle including any component, part or accessory, which is 3

4 A Medical Device Is 1. Recognized in the official Na&onal Formulary or the U.S. Pharmacopoeia, or any supplement to them, 2. Intended for use in the diagnosis of disease or other condi&ons, or in the cure, mi&ga&on, treatment, or preven&on of disease, in man or other animals, or 3. Intended to affect the structure or any func&on of the body of man or other animals, and 4

5 A Medical Device Is which does not achieve its primary intended purpose through chemical ac&on within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose. 5

6 There is No Defini&ve List Product spectrum highly diverse and complex Decision requires detailed review of manufacturer s intent Labeling claims Adver&sing materials Oral and wriyen statements by manufacturer An&cipated misuse Standalone sozware a.k.a. sozware only devices SoZware intended to run on general purpose computers Credit: John Murray, FDA 6

7 Examples of Regulated SoZware Blood bank sozware Picture Archiving and Communica&ons Systems Lab Informa&on Systems Drug dose calcula&on, e.g., Tight Glycemic Control protocols Stent selec&on sozware Radia&on therapy planning Clinical scoring systems sozware Medical Device Data Systems (Pending) 7

8 FDA Posi&on on EMRs EMRs are currently classified as electronic record keeping systems and are not considered a sozware medical device Decision Support intended for use in the diagnosis of disease or other condi&ons, or in the cure, mi&ga&on, treatment, or preven&on of disease, in man or other animals is already a medical device 8

9 Adverse Events Reported Arch Intern Med. 2005; 165: Pediatrics 2005; 116:

10 FDA Considers Regula&ng Safety of Electronic Health Systems Huffington Post story 2/23/10 FDA's voluntary no&fica&on system logged a total of 260 reports of "malfunc&ons with the poten&al for pa&ent harm," including 44 injuries and the six deaths Dr. Jeffrey Shuren tes&fies at HHS 10

11 Key Ques&ons Does it meet the legal defini&on of a device? Does not have to be all inclusive Is it simply an electronic version of some exis&ng library source material? Does it meet the defini&on of an exis&ng classifica&on? Is it an accessory to an exis&ng medical device? Is it intended for use in a pa&ent specific manner? What is the risk and the interven&on case? Credit: John Murray, FDA 11

12 FDA Thought Process If it impacts health, FDA gets interested Their natural reac&on is to interpret the scope of their authority very broadly and then &er it, making dis&nc&ons based on risk FDA does not care if it's complex or if their involvement will slow down important technologies. High complexity + high public health involvement = FDA involvement Bradley Merrill Thompson, Esq. Epstein Becker Green 12

13 FDA Thought Process If FDA is now thinking about regula&ng EMRs, then FDA will probably have a view on the hardware and sozware in between the pa&ent and the EMR It's not far, then, to look at mhealth and possible regula&on of smartphones Conclusion: this is the beginning of a conversa&on, Dr. Shuren is not being dogma&c and is looking for best approaches (this is a tone point that I expect will be debated) The approach will start and end with concern for the pa&ent 13

14 Regulatory Conflicts Office of the Na&onal Coordinator Tests and cer&fies EMRs as providing required func&onality FDA Regulates manufacturers to ensure safe and effec&ve opera&on of medical devices Emerging conflict as to who will regulate EMRs 14

15 Agenda The case for regula&ng Impact on manufacturers Impact on providers Recommenda&ons and best prac&ces 15

16 State of the Industry Write sozware without documented or complete requirements LiYle or no traceability between requirements and tes&ng Insufficient tes&ng: scalability, sta&c analysis LiYle or no post- market surveillance of installed products 16

17 State of the Industry Poor usability and user interface design Defects in sozware Defects in configura&on Legacy code Lack of documenta&on Spaghev code Absence of knowledgeable engineers 17

18 Quality System Regula&on Basic quality system similar to ISO9001 Equivalent to Capability Maturity Model level 3 Correc&ve and preven&ve ac&on (CAPA) system 18

19 Agenda The case for regula&ng Impact on manufacturers Impact on providers Recommenda&ons and best prac&ces 19

20 Impact on Providers Higher purchase price from HIT vendors (but probably not a lot, due to compe&&on) Longer &me to market Elimina&on of engineering specials Much higher opera&ng costs, though providers should be able to leverage some IEC investments Hospital as system integrator: EMR, MDDS, DSS, meds admin 20

21 Provider Responsibili&es Risk management will need to be beefed up considerably - beyer governance, beyer documenta&on, deeper more substan&al risk management focus Change control will also need to be brought up a few notches in many organiza&ons, and expect to be driven by product recalls and other post- market surveillance results Post market repor&ng of all adverse events 21

22 Provider Responsibili&es Providers will be challenged when it comes to modifying purchased EMRs if they are a regulated medical device Gray area of the law Not an off label use which is allowable Leverages legal theory of the prac&ce of medicine FDA looks the other way, provided No marke&ng claims are made by the provider The modifica&on is not sold to other providers There are no adverse events as a consequence Risk management is paramount 22

23 Systems of Systems Interoperability and connec&vity add complexity and risk between Similar systems in other provider organiza&ons Between informa&on systems in the enterprise, and Between EMRs and medical device systems 23

24 Communica)ons Phones Barcode Readers Computers on Wheels Pagers PDAs Overhead Pages Nurse Call PoC Diagnos)cs Pa)ent Care Ven)lators Pa)ent Monitors IV Pumps Telemetry Packs Spot Vital Signs Monitors Pa)ent Assessments Alarms Meds Administra)on Documenta)on Coordina)ng Care Pa)ent Educa)on Tasks Medical Devices 24

25 Agenda The case for regula&ng Impact on manufacturers Impact on providers Recommenda&ons and best prac&ces 25

26 Opera&ons Test, test, test! The system of systems installed in any one loca&on is unique and has never been tested by any one manufacturer - just manufacturers tes&ng their own bits and pieces Start with hazard and risk analysis Test plans modeled on actual workflow Realis&c test environments Controlled repeatable tests Fully documented Start with IEC now 26

27 Policies and Procedures Backup Change Control Data Restora&on High Reliability Systems Library and Document Control Medical Device PM Monitoring OS Patch Applica&on PCDI SOP Physical Security and Access Problem Iden&fica&on Problem Resolu&on Repair Valida&on Risk Management Security and Privacy Sen&nel Events Service Model Severity Level Staff Roles Test and Cer&fica&on Time Sync UPS Ven&la&on and Cooling Virus Protec&on 27

28 Human Resources The slow trickle of IT people currently leaving hospitals for banks, big box retailers and other IT- intensive and low- risk employers will grow considerably 28

29 Human Resources New skill sets to match new responsibili&es Systems engineering Quality systems Blend of clinical engineering, risk management and IT 29

30 Contact Informa&on Tim Gee Principal Consultant Santa Rosa Consul&ng (503)

31 Bibliography CDRH Regulated SoZware hyp://www.fda.gov/downloads/training/cdrhlearn/ucm pdf General Principles of SoZware Valida&on hyp://www.fda.gov/medicaldevices/deviceregula&onandguidance/ guidancedocuments/ucm htm Quality System Regula&on hyp://www.fda.gov/medicaldevices/deviceregula&onandguidance/ PostmarketRequirements/QualitySystemsRegula&ons/default.htm Capability Maturity Model hyp://en.wikipedia.org/wiki/capability_maturity_model 31

32 Bibliography Huffington Post story hyp://huffpos{und.org/stories/2010/04/doctors- shiz- electronic- health- systems- signs- harm- emerge Workarounds to Bar Code Medica&on Administra&on Systems hyp://jamia.bmj.com/content/15/4/408.abstract Jeffrey Shuren HHS Tes&mony hyp://www.govhealthit.com/newsitem.aspx?nid=73210 ISO Risk Management Standard hyp://www.aami.org/publica&ons/aaminews/nov2010/iec80001.html Sta&c analysis sozware tes&ng hyp://en.wikipedia.org/wiki/sta&c_code_analysis 32

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