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1、Compliance with FDA Regulations:Collecting, Transmitting and Managing Clinical InformationDan C PettusSenior Vice PresidentSenior Vice PresidentiMetrikus, Inc.iMetrikus, Inc.What does Regulation Mean?n nFor devices, drugs, etc., it means the manufacturer is For devices, drugs, etc., it means the man
2、ufacturer is held accountable for GMP and QSR under Title 21 held accountable for GMP and QSR under Title 21 parts 1 to 1299 (e.g., part 801- Labeling, part 820 parts 1 to 1299 (e.g., part 801- Labeling, part 820 Quality System)Quality System)n nAbility to electronically authenticate is permitted un
3、der 21 Ability to electronically authenticate is permitted under 21 part 11 of the FDA regulationspart 11 of the FDA regulationsn nThe FDA issued guidance documents which identify The FDA issued guidance documents which identify portions of title 21 part 11 as being applicable for portions of title
4、21 part 11 as being applicable for clinical trials submissionsclinical trials submissionsNOTE: Clinical Information may be regulated by additional state and NOTE: Clinical Information may be regulated by additional state and federal agencies. HIPAA is a good example. federal agencies. HIPAA is a goo
5、d example. Confused?25 Years in technology development20 Years in Healthcare InformaticsWhen it comes to FDA (HIPAA, and others) regarding regulatory requirements for telemedicine and clinical data . and Im still confused?A Device isAccording to the FDA, a device is:According to the FDA, a device is
6、:n nan instrument, apparatus, implement, machine, contrivance, implant, in an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component vitro reagent, or other similar or related article, including a component part,
7、or accessory which is:part, or accessory which is:n nrecognized in the official National Formulary, or the United States recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, Pharmacopoeia, or any supplement to them, n nintended for use in the
8、diagnosis of disease or other conditions, or in the intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other cure, mitigation, treatment, or prevention of disease, in man or other animals, or animals, or n nint
9、ended to affect the structure or any function of the body of man or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended other animals, and which does not achieve any of its primary intended purposes through chem
10、ical action within or on the body of man or other purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purp
11、oses. achievement of any of its primary intended purposes. If the primary intended use of the product is achieved through chemical If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. action or by being met
12、abolized by the body, the product is usually a drug. Human drugs are regulated by FDAs Human drugs are regulated by FDAs Center for Drug Evaluation and Center for Drug Evaluation and ResearchResearch (CDER). (CDER). When is a device a device?n nDiagnostic Patient Monitoring yesn nElectronic Medical
13、Record Systems no?n nICU Clinical Data Management Systems no?n nAnesthesia Data Management Systems depends on who you ask?n nTelemedicine maybe?Case History - ARKIVEn n1985-1986: Ohmeda develops a 1985-1986: Ohmeda develops a semiautomatic electronic anesthesia record semiautomatic electronic anesth
14、esia record keeper as an “accessory” to its gas machinekeeper as an “accessory” to its gas machinen n1986 Arkive files 510(k) as an anesthesia 1986 Arkive files 510(k) as an anesthesia information system. FDA classifies Arkive a information system. FDA classifies Arkive a gas machine accessory. FDA
15、is informed gas machine accessory. FDA is informed that Arkive is a stand-alone information that Arkive is a stand-alone information management system and not an accessory to management system and not an accessory to anything. FDA response reclassify anything. FDA response reclassify Arkive no longe
16、r an accessory its now a Arkive no longer an accessory its now a “gas machine”? “gas machine”? Is Telemedicine device?Although FDA does not regulate the delivery of health care services or the transmission of information related to care between physicians and patients, FDA does regulate the commerci
17、alization of technologies associated with health care delivery (devices). As FDA has stated; “The use of advanced telecommunications technology to deliver health care brings with it a host of concerns about safety and effectiveness.” In its White Paper, FDAs Center for Devices and Radiological Healt
18、h (CDRH) declared that many “products” used in telemedicine are medical devices subject to regulatory authority.Clinical Data is Regulated When:n nIt is part of a clinical trialn nIt is embedded as part of a regulated devicen nThe data acquisition is an accessory to a regulated device Accessory to a
19、 regulated device is a bit fuzzy Accessory to a regulated device is a bit fuzzy In Generaln nThe collection, transmission, and management of clinical data for the purpose of care management and medical treatment is not usually regulated by the FDAn n(May be regulated by other agencies and laws, e.g.
20、, (May be regulated by other agencies and laws, e.g., HIPAA)HIPAA)n nReasonable efforts should be used to avoid deliberate or accidental disclosuren nPatients have rights under state laws and HIPAA regarding privacy and disclosureBest Practicen nPolicies and operating procedures that clearly describ
21、e your organizations collection and use of clinical datan nBusiness Associate Agreement under HIPAABusiness Associate Agreement under HIPAAn nBest practice to protect a patients privacyn nBest practice to ensure security throughout the networkn nRegular audits that validate your processExample of Te
22、chnology SecuritySummaryn nWith regards to clinical information, the FDA regulates devices and drug submissions (clinical trials)n nYour organization may be required to comply with FDA if the clinical information is part of a clinical trialn nMay be subject to other state and federal (HIPAA) regulations
