Key StandardsComplianceRegulatoryThatHealthcareSoftwareDevelopersShouldKnowAbout
Itisnoteasytobuildhealthcaresoftwarefromscratch.Ittakesalotofworktoensurethatthe softwarerunssmoothlyandmeetsallcompliancerequirements.Thisiswheremanycustom healthcaresoftwaredevelopmentprojectsfallapart.
Compliancewithregulationsissomethingthatshouldnotbetakenlightly.Non-compliance withdatasecurityregulationsisaseriousmatter.Companiesresponsiblewillbepunished harshly.Ahealthcaresoftwareproviderwashitwithastaggering$1.5millionfinebyFrench dataprotectionauthorities.Penaltiesforsecurityviolationsbyhealthcarecompaniesinthe USAcanreachupto$1.5million.
Thedevilisalwaysindetails.Andthefinerpointsofregulationscangetyouintotrouble.
Thehealthcareindustryisgovernedbyregulations,justlikeanyotherindustry.Theseregulations determinewhatislegalorillegal. Eachcountryhasitsownregulationsthatthehealthcareindustrymustfollowwhenimplementing healthcaresoftwaresolutions.Belowaresomeofthemostimportantregulations. 1. HealthInsurancePortabilityandAccountabilityAct,(HIPAA)-USA 2. FederalFood,Drug,andCosmeticAct(FFDCA-USA) 3. FoodandDrugAdministration(FDA),USA 4. HealthInformationTechnologyforEconomicandClinicalHealthAct-USA 5. OfficeoftheAustralianInformationCommissioner(OAIC),Australia 6. PersonalInformationProtectionandElectronicDocumentsAct,Canada 7. GeneralDataProtectionRegulation(GDPR),TheEuropeanUnion-EuropeanUnion WhatareRegulatoryCompliancesfor HealthcareProducts?
Privacyanddatasecurityarethemainconcernswhenitcomesto healthcaresoftware Cyberdevelopment.attacksareconstantlythreateningthedigitalworld.Naturally,healthcare solutionscanalsobeatrisk.Digitalstorageisusedtostoresensitiveinformationthat patientssharewiththeirhealthcareproviders.Thissoftwareoftenusescloud computingtechnologytofunction.Thesecyberspacesarevulnerabletodatatheftand attacks.
WhyIsItEssentialtoFollowRegulatoryCompliance inHealthcareSoftwareandAppDevelopment? Privacy&DataSecurity
Theseregulationsdonotjustprotectdatabutarepartofanoverallefforttoward makinghealthcaremorepatient-centric.Theseregulationsrequirethatthe healthcareITproviderputsthepatient'sinterestsfirstandtakeseveryprecautionto avoidanymissteps.Italsopreventsfraudinthehealthcaresystembyensuringthat nopatientisexploitedbybigbusiness.Dataprotection,inconjunctionwiththe previouspoint,protectspatientsfromanyemotionalharmthatidentitytheftordata losscancause.
Patient-CentricCare
AvoidFinesandfinanciallosses
Sometimes,thepriceofnotfollowinggovernmentregulationscanbetoohigh.Thisisa seriousmatterthatshouldnotbeoverlooked.Ifthesoftwareisnotincompliancewith regulations,finescanreach$1.5million.
Iftheseprecautionsarenottaken,healthcareserviceproviderscansuffersevere losses.Healthcareproviderscouldfallforcyber-trickssuchasdatabreachesand holdingdatahostageforransom.
Thesearejustafewofthecompliancereasons.Let'stakealookatthecompliance requirementsforhealthcaresoftwaredevelopers.
Youcannotmakeyoursoftwareproductworkinthepublicsectorifitdoesn'thave theapprovaloftheseregulatorybodies.Itisimpossibletomoveforwardwithouta certificateofconformity.Theseproblemscanonlybesolvedbyupdatedregulations.
RegulatoryApproval
RegulatoryCompliancesforHealthtech ProductsinDifferentCountries
FFDCA–USA
Numerousregulationsareenforcedinthehealthcaresector.Itisnotadeterrentbuta meanstobetterservicesandbenefitsforeveryone.Thesearesomeofthemost important:
Developed
MedicaldevicesaregovernedbytheFederalFood,Drug,andCosmeticAct.This includeshealthcaresoftware,pharmaceuticals,andmanyotherproducts.Before obtainingcompliancewiththeFFDCA,youmustfirstmeetseveralapprovalssuchas thePMA(Pre-MarketApproval),Pre-CertProgram(DigitalHealthSoftware Pre-CertificationProgram),SaMD[SoftwareasaMedicalDevice],andtheLDT (“Laboratory Test).
HITECHHIPAA–USAAct-USA
The1996HealthInsurancePortabilityandAccountabilityAct(HIPAA)outlinesthe guidelinesonemustfollowinordertocollect,storeandtransferpersonaldatafrom customers.Healthcarefacilitiesthatfailtocomplycanbesued. YoumustcomplywithHIPAAregulationsifyoursoftwareinvolvesPHI(protected healthcareinformation),EMRs,orEHRs(electronicrecordsofmedicalrecords)
Topromotemeaningfuluseandadoptionofhealthinformationtechnology,the HITECHAct(HealthInformationTechnologyforEconomicandClinical)wascreated. ThislawrequireshealthcareproviderstoadheretoHIPAAregulations.
FoodandDrugAdministration(FDA)
Eachsoftwareapplicationandeverystandalonedevicethatisintendedformassuse mustbesubjecttothestrictscrutinyoftheFDA,andtheUnitedStatesDepartmentof HealthandHumanServices.TheFDAreviewsthesoftwaretoensurecompliancewith regulationsbeforeapprovingitsuseanddistributiontothepublic.
OAIC–Australia
TheOAIC,orOfficeoftheAustralianInformationCommissioner,managesregulations pertainingtothedistributionanduseofsoftwareandhealthcaretechnologies.It outlineshowpersonalinformationaboutpatientsiscollectedandstored.Patients havefullcontrolofsensitivedata.Intheeventofdatabreaches,healthcareproviders mustprovidecompletenetworksecurityandreportsimmediately.
GeneralDataProtectionRegulation(GDPR)-TheEuropeanUnion
PersonalInformationProtectionandElectronicDocumentsAct,2000(PIPEDA), governspersonalinformationthatbusinessesuseforcommercialpurposes.Although itissimilartoHIPAAinmanyrespects,italsoprovidesdataprotectionformedical applications.Foreachviolation,itcanimposeamaximumof$100,000.
ItisgenerallyvalidwithintheEuropeanUnion.TheGDPRexpandsthescopeof sensitivedataincomparisontootherregulatorybodies.Thisincludesbiometricdata andgeneticdataaswellasIPaddressesanddataonracial,ethnicorigin,andreligion. Individualshavetherighttowithdrawtheirconsentatanytime.
PIPEDA–Canada
Beforetheproductislaunched,compliancewithregulationsand customhealthcare appdevelopmentmustfirstbeconsidered.It'sbettertoknowandfollowthe regulationsthantofacefinanciallossandlegalactionfromthegovernment.You mustverifythattheyarenotinviolationoftheregulationsorhavebeensubjectto legalactionbeforeyouhirethem. Hereinthisblog youcanfindallKeyRegulatoryComplianceStandardsThat HealthcareSoftwareDevelopersShouldKnowandfollowwhiledevelopinga healthcaresoftware.ToknowmoreaboutkindlyrequestafreequoteatEMed HealthTech Conclusion
www.emedhealthtech.com 079 48001671info@emedhealthtech.com
